Postoperative awake prone position in geriatric patients with hip fracture: a protocol for a randomized controlled trial on the efficacy of postoperative prone position in reducing pulmonary complications and improving oxygenation

doi:10.21203/rs.3.rs-2633071/v1

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Research Article

Postoperative awake prone position in geriatric patients with hip fracture: a protocol for a randomized controlled trial on the efficacy of postoperative prone position in reducing pulmonary complications and improving oxygenation

https://doi.org/10.21203/rs.3.rs-2633071/v1

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published 18 Apr, 2023

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Introduction Postoperative pulmonary complications (PPCs) are prevalence in geriatric patients with hip fractures. Low oxygen level is one of the most important risk factors for PPCs. Prone position has been proven efficacy in improving oxygenation and delaying the progress of pulmonary diseases especially in patients with acute respiratory distress syndrome induced by multiple etiologies. The application of awake prone position (APP) has also attracted widespread attention in recent years. A randomized controlled trial (RCT) will be carried out to measure the effect of postoperative APP in a population of geriatric patients undergoing hip fracture surgery.

Methods This is a RCT. Patients older than 65 years old admitted through the emergency room and diagnosed with an intertrochanteric or femoral neck fracture will be eligible for enrollment and randomized to control group with routine postoperative management of orthopedics or APP group with additional prone position for the first three consecutive postoperative days (PODs). Patients receiving conservative treatment will not be eligible for enrollment. We will record the difference in patient’s room-air-breathing arterial partial pressure of oxygen (PaO₂) values between the 4^th POD (POD 4) and emergency visits, morbidity of PPCs, mortality and ICU stays during hospitalization, length of hospitalization. The rates of PPCs, readmissions and mortality will be followed up for 90 PODs.

Discussion

We describe the protocol for a single-center RCT that will evaluate the efficacy of postoperative APP treatment in reducing pulmonary complications and improving oxygenation in geriatric patients with hip fracture.

Ethics and dissemination: This protocol was approved by the independent ethics committee (IEC) for Clinical Research of Zhongda Hospital, Affiliated to Southeast University and is registered on Chinese Clinical Trial Registry. The findings of the trial will be disseminated through peer-reviewed journals.

Ethics approval number: 2021ZDSYLL203-P01

Trial registration: ChiCTR, ChiCTR2100049311. Registered on 29 July 2021, https://www.chictr.org.cn/listbycreater.aspx

Trial status: Recruiting. Recruitment is expected to be completed in December 2024.

hip fracture

geriatric

awake prone position

postoperative pulmonary complications

hypoxemia

Given the aging population, the increasing number of geriatric hip fractures has become a tremendous health burden for society globally [1, 2]. For such patients, active surgical treatment has been proved optimal compared with conservative treatment [3]. Geriatric patients are characterized by fragility and multi-comorbidities, which brings a challenge for perioperative management and preoperative rehabilitation [4]. Postoperative complications are always inevitable and impact considerably on prognosis of geriatric hip fractures [5, 6], among which, postoperative pulmonary complications (PPCs) were the commonest one and the incidence rate was up to 12.6% [7–11]. The PPCs are considered to be a highly heterogeneous group of diseases [12]. It usually brought extended length of stay (LOS), increased health care costs, readmission and even mortality [12–15]. Low oxygen level was one of the independent risk factors of PPCs [16]. Postoperative hypoxemia was persistent and more common than preoperative period [17], which consists with our preliminary observations. Canet J. pointed out that the morbidity of PPCs would increase significantly if preoperative arterial oxygen saturation (SaO₂) was less than 90% [18]. Russotto V. also discovered that the morbidity of postoperative pneumonia (POP) was in liner negative correlation with preoperative SaO₂ [14]. Moreover, arterial partial pressure of oxygen (PaO₂) level was a simple predictor of POP with high acceptance in geriatric hip fracture patients and the cut-off value was 72.5 mmHg, which met the standard of hypoxemia (PaO₂＜80mmHg) [19–21].

Nowadays, prone position ventilation was widely applicated in adjuvant therapy for acute respiratory distress syndrome (ARDS), especially secondary to coronavirus disease 2019 (COVID-19) and recommended in the international guideline for management of critical COVID-19 patients [22]. Recently, prone positioning in non-intubated or awake prone position (APP) characterized with simple mechanism of action and perceived low risk has also received lots of interest and brought positive effect [23].

For geriatric patients with hip fractures, no widely accepted, long-term, feasible intervention with provable evidence to treat PPCs has been proposed [24, 25]. Lying in the lateral position intra-operatively could improve postoperative PaO₂/ fraction of the inspired oxygen (FiO2) (P/F) and reduce the need for invasive or non-invasive ventilation in patients with femoral neck fracture (FNF), which remained us change of body position may help to better respiratory function via gas exchange for such patients [26]. We hypothesize that the application of the APP will reduce the risk of PPCs and improve postoperative oxygenation (expressed as P/F) in geriatric patients with hip fractures, an ideal population for randomized controlled trial (RCT).

Objective

To investigate the hypothesis that the APP would reduce the incidence of PPCs and elevate the room-air-breathing P/F in geriatric patients with hip fractures.

Overview of trial design

We conducted a single-center RCT using a completely randomized two-arms design to investigate whether APP would decrease the morbidity of PPCs and improve postoperative oxygenation for geriatric patients with hip fracture (Fig. 1and Fig. 2). The Standard Protocol: Items: Recommendations for Interventional Trials (SPIRIT) checklist [27] is provided as Additional file 1. All patients considered for inclusion are admitted from the emergency department to the Trauma and Orthopedic Unit of the Zhongda Hospital affiliated to Southeast University and would be operated by the same team in a fixed operating room. A designated investigator employed a 1:1 randomization system to assign patients who met the criteria to the APP group and the control group. Patients enrolled in the study will be followed for 90 PODs.

Patients would undergo a review of hematological parameters including routine blood, biochemistry, electrolyte, blood gas analysis on POD 4. Clinical pulmonary infection score (CPIS) [28] (Additional file 2) will also be calculated on POD 4. The incidence of various postoperative complications, mortality rate, and LOS during hospitalization were recorded. At the same time, the incidence of postoperative complications, especially PPCs, readmission and mortality will be calculated on POD 30 and 90, respectively. This protocol was approved by the independent ethics committee (IEC) for Clinical Research of Zhongda Hospital, Affiliated to Southeast University (2021ZDSYLL203-P01) and is registered on Chinese Clinical Trial Registry (ChiCTR2100049311). Only the head of this series of researches (YR) has the right to make the final decision to terminate the trial if any serious adverse event judged to be related to the study treatment occurs.

Primary Research Question

In geriatric patients with hip fractures, does the addition of APP to routine postoperative treatment reduce the risk of developing PPCs?

Secondary Research Question

In geriatric patients with hip fractures, does the addition of APP to routine postoperative treatment result in:

Improved postoperative oxygenation?

Shorter LOS?

Decreased incidence of other kinds of postoperative complications, readmission and mortality?

Hypothesis

Compared with the control group, geriatric patients with hip fractures who received postoperative APP treatment had a lower incidence of PPCs during the first 30 PODs and an improved postoperative oxygenation.

Setting And Participants

Geriatric patients (over 65 years old) presenting to the emergency department with an acute hip fracture after September 1, 2021, will be screened for eligibility and enrolled by an investigator (YG). All potentially eligible patients are admitted to Trauma and Orthopedic Unit of the Zhongda Hospital affiliated to Southeast University. Prior to admission, trauma center physicians will take the patient's medical history, risk assessment, physical examination, necessary laboratory and imaging tests.

Once confirmed to receiving surgical treatment, the research implementer (YG) will represent informed consent for participants in the study using the approved IEC Informed Consent Forms (Additional file 3). All patients will understand that depending on the randomization results, they may or may not receive a postoperative prone position. Participants in the study are voluntary, and if they refuse, their decision will not affect any other aspect of their care. Patients will have the right to learn any details of the intervention and to withdraw from the study at any point.

Inclusion criteria

Patients meeting the following criteria will be considered for eligibility:

Aged over 65
Informed consent and voluntary participation in a clinical trial
Diagnosed with acute hip fracture induced by low-energy injury including intertrochanteric fracture and FNF within 14 days before admission
In at least one of the following conditions:
1. Type 2 Diabetes Mellitus (T2DM)
2. Chronic lung disease such as chronic obstructive pulmonary disease
3. Pre-injury activities of daily living (ADL) score < 5
4. Modified British Medical Research Council (mMRC) score ≥ 2
5. First result of leukocyte count > 10 × 10⁹/L or C-reaction protein (CRP) > 15 mg/L at admission
6. First result of PaO₂ < 80 mmHg or SaO₂ < 96% at the time of admission
7. First result of hemoglobin < 100 g/L at the time of admission
8. First result of serum albumin < 35 g/L at the time of admission
9. Previous history of smoking and sleep apnea syndrome
Able to remain in a prone position for at least 30 consecutive minutes
Intertrochanteric fracture patients receiving closed reduction and internal fixation (proximal femoral locking gamma nail); FNF patients receiving posterior approach uncemented total hip arthroplasty (THA) or hemiarthroplasty (HHA) as procedure methods

Exclusion criteria

Patients meeting the following criteria will be considered for exclusion.

With life-threatening organ dysfunction, decompression sickness or unable to disengage from guardianship or non-invasive/invasive mechanical ventilation
With pulmonary comorbidities that included in PPCs before surgery
With osteosarcoma, multiple myeloma, and various other pathological fractures
With multiple fractures or injuries
With a bilateral hip fracture
Receiving hip revision surgery
With history of major cardiac and pulmonary surgery
In an immune-disorder condition caused by various causes (malignant tumors, severe autoimmune diseases, long-term hormone use, etc.)

Baseline

Baseline assessment includes, gender, age, body mass index (BMI), type of fracture, time from injury to surgery, pre-injury ADL score, mMRC score, American Society of Anesthesiologists classification and comorbidities including pulmonary disease according to the first result of thoracic computerized tomography (CT) at admission [atelectasis, pleural effusion, chronic obstructive pulmonary disease], hypertension, T2DM, coronary atherosclerotic heart disease, cognitive dysfunction, prior stroke, cerebral infarction, history of smoking and drinking, first laboratory results of arterial blood gas analysis [PaO₂, PaCO₂, SaO₂, pH, lactic acid], routine blood test (erythrocyte count, leukocyte count, CRP, hemoglobin), biochemistry test (serum albumin, blood glucose, blood creatinine, blood urea nitrogen), electrolyte test (serum potassium, serum sodium), D-dimer, brain natriuretic peptide (BNP), time from injury to surgery, proportion of receiving surgery within 48 hours after admission, surgical procedures (closed reduction and internal fixation, THA or HHA), methods of anesthesia (general or epidural anesthesia), postoperative respiratory failure risk index [29] (Additional file 4), POP risk index [30] (Additional file 5), duration of surgery, perioperative blood transfusion volume and LOS.

Randomization and allocation

Randomization will take place once participants have signed informed consent for the procedure. SAS software 9.4 is used to generate the random table as allocation sequence by an investigator (LS) and random numbers will be assigned by envelope method. Based on random numbers, another investigator (TX) assigned patients to APP group or control group in a 1:1 ratio. Details of any planned restriction will be provided in a separate document that is unavailable to those who enroll participants or assign interventions.

Blinding

Keeping trial participants and care providers blinded is unrealistic. But neither the outcome assessors nor the data analysts are aware of the grouping. Grouping information will be represented to data analysts in the form of group A/B rather than APP group and control group. During the data analysis phase, all personal information that can be used to identify the participants will be hidden.

Intervention

After signing informed consent, participants will be enrolled and randomly assigned to either the APP group or the control group. Surgical treatment will be performed on an emergency basis upon completion of the necessary pre-operative preparations. The surgical procedures, including closed reduction and internal fixation, THA and HHA, will be decided by the chief physician (HC and YR) in trauma orthopedics. All operations will be scheduled in a fixed operating theatre and completed by the same team. Patients in the APP group will receive the prone position for at least half an hour at a time, and at least once per day for the first three consecutive PODs. The first prone position treatment each day will be guided and supervised. The frequency and duration of other spontaneous prone positions in the APP group will not be constrained. Except for this, during this period, all patients will receive the same postoperative management including postoperative oxygen inhalation (2L/min) for 6 hours, standardized nutritional support, anti-inflammatory, detumescent, analgesic, hypodermic anti-coagulant prophylaxis and regular atomization therapy. Both FNF and intertrochanteric fracture patients roll onto their broken side into a prone position. Prone position pads will be used to suspend the upper abdomen and chest to reduce intra-abdominal and intra-thoracic pressure, allowing the alveoli to expand sufficiently. If severe adverse events such as unbearable pain, suspected prosthesis dislocation or internal fixation failure, chest tightness, and difficulty breathing occur, or the patient reports that he/she cannot tolerate the supine position, the intervention should be stopped immediately. The investigator's department will treat and compensate the patient for any additional injuries resulting from APP treatment. Intervention time as an adherence quantitative indicator and the reasons for cease will be recorded in the database. Hematological parameters and chest radiography will be re-examined on the morning of POD 4. Patients will be followed up for 90 PODs through outpatient visits or telephone calls. In addition to orthopedic-related tests, they will undergo chest CT in an outpatient setting to determine if PPCs are present. The conduct of the trial will be audited weekly, independently of the investigators.

STANDARD OF DISCHARGE: 1. The x-ray shows that the position of the internal fixation/prosthesis is in place. 2. The incision is essentially healed, and no signs of infection are found. 3. No serious complications have occurred requiring continued hospitalization. 4. The serological test results and the general condition of the patient are acceptable.

Primary outcome

The primary outcome of the study will be the incidence of PPCs during the first 30 PODs. PPCs include all related diseases (atelectasis, POP, ARDS, pulmonary embolism, pleural effusion, pneumothorax, cardiogenic pulmonary edema, and bronchospasm) diagnosed anywhere within the first 30 PODs.

Secondary outcome

The secondary outcomes will be PaO₂ on POD 4, the difference in PaO₂ values between POD 4 and emergency visits (EV), CPIS on POD 4, LOS, other types of post-operative complications, readmission, and mortality in 90-day follow-up.

Given that FiO₂ is equal to 20.9% of the breathing room air, we use PaO₂ instead of P/F to reflect the patient's oxygenation capacity. On the morning of POD 4, the patient will undergo arterial blood gas analysis while inhaling room air. We anticipate that postoperative oxygenation (expressed as PaO₂), will be higher in the APP group than in the control group. To minimize the impact of the baseline oxygenation capacity of different participants on the results, we use the difference in PaO₂ values between POD 4 and EV to balance out this individual difference. Additional tests are required for the diagnosis of complications, such as chest CT, pulmonary and coronary CT angiography, brain CT, arterial blood gas analysis, myocardial X-ray, troponin and BNP, and will be performed as soon as suspicious symptoms such as dyspnea, chest distress, fever, cough, sputum and motor, sensory or cognitive dysfunction appear. All post-operative complications will be diagnosed following consultation with the appropriate specialist. Readmission and mortality rates within 30 or 90 PODs will be calculated separately. All serious adverse events, as well as all non-serious adverse events that are unexpected and determined to be related to the APP treatment, will be recorded in the study database and reported on request to the IEC for Clinical Research of Zhongda Hospital, Affiliated to Southeast University.

Sample size consideration

According to the result of pilot study, the sample size was 200 (100 in APP group and 100 in control group respectively) if taking the incidence of PPCs within the first 30 PODs as primary outcome and 20% as loss rate [31].

Data Collection And Analysis Plan

All data will be collected and stored in case report form (Additional file 7) by two well-trained assessors (WG, MC) independently. Any discrepancies will be checked by the same two assessors to ensure accuracy and authenticity. All information will be aggregated in the final trial dataset, which is accessible only to LS and will only be shared with research team members upon request for the completion of the designated learning task. All information related to patient identification will be hidden before it is uploaded to a public database. Descriptive analyzes of the patient population will include reporting means (with SDs) for normally distributed variables, medians (with Q1, Q3) for skew-distributed variables, frequencies (with percentages) for categorical variables. Student t-tests will be conducted to analyze normally distributed variables. The Mann-Whitney U test will be used for skew-distributed data and ordered categorical variables. Chi-squared tests are used to analyze binary or unordered categorical variables. The balance of baseline data and differences in post-operative outcomes were assessed in terms of the above variables. To control other covariates, including stratification factors (gender and fracture type) and baseline variables that have potential relation with the outcome, as well as any such variable that appears imbalanced between APP group and control group, multiple logistic regression model will be conducted to analyze the related factors of PPCs at each point of time (POD 30 and 90). Similarly, we will perform a multivariate linear regression analysis to determine which variables are independently related to the difference values in PaO2 between POD 4 and EV. All analysis will be performed using the SPSS 23.0 software. Any outcome data collected for participants who discontinued or deviated from the intervention protocol will be listed. Primary and secondary outcome analysis will not allow missing data. Other missing values are assumed to show no significant difference from other data we have collected; If missing values suggest that the missingness is not random, we will assess the potential impact of missing data on our results via a developmental model.

Patient And Public Involvement Subsection

Patients and the public will not be involved the design, or conduct, or reporting, or dissemination plans of the research.

PPCs in geriatric patients with hip fracture

Prolonged bed rest, acute lung injury (ALI) induced by trauma, airway abrasion and oedema caused by endotracheal intubation, shallow respiration and insufficient ventilation resulted from anesthetic and muscle relaxant residue all contributed to the occurrence of PPCs [32]. The prevalence of PPCs in geriatric patients with hip fracture was the highest among postoperative complications, reaching up to 12.6% [7–11]. However, the existing clinical treatment measures are not satisfactory. So, we are urgently looking for more suitable and effective adjuvant therapies, and if a simple, feasible, invasive and inexpensive measure can benefit such patients, it would be worth considering.

PPCs can be divided into two categories, one group with the same pathophysiological mechanisms of airway collapse and contamination, including atelectasis, POP, respiratory failure, ARDS, and the others without a common physiological mechanism, which should be evaluated separately, such as pulmonary embolism, pleural effusion, pneumothorax, cardiogenic pulmonary edema, and bronchospasm [33]. Among the subtypes of PPCs following hip fracture surgery in the elderly, POP and respiratory failure are the major components. The incidence of POP is up to 3.5 ~ 15.2% [34] and could bring a 30-day mortality rate up to 27–43% in geriatric patients with hip fracture [35, 36]. Postoperative respiratory failure is significantly associated with preoperative hypoxemia, which is highly prevalent in geriatric patients with hip fracture [37]. Given this, we will specifically evaluate the risk of POP and respiratory failure in participants to further determine the comparability of the two groups prior to intervention.

The Physiological Viewpoint Of Prone Position

In order to avoid fracture displacement and the extreme pain caused by stimulation of pulled periosteum after injury, supine position was used for injured limb braking. In supine position, due to gravity, the compression of the heart and mediastinum on the lower lobe of the lung and the mismatch between the spherical thoracic cavity and the triangular lung led to compressive atelectasis. The alveoli, especially the dorsal alveoli, are limited in expansion, resulting in a mismatch of ventilation-perfusion ratio and relative shunt fraction, and ultimately the decline of oxygenation index [38, 39]. Prone position can reduce the pressure gradient of the vertical pleura and the compression of the lung lobe to preferentially distribute lung perfusion in the dorsal region, reduce local alveolar abnormalities resulted from increased tension and stress changes, and limit the overexpansion of healthy areas, and eventually improve lung hemodynamics, optimize the pulmonary ventilation blood flow ratio, reduce airway resistance, improve oxygenation index, promote alveolar expansion, reduce the risk of infection [40–44].

Clinical Application Of Prone Position Treatment

Earlier researches have shown that prone position ventilation may reduce the incidence of ventilator associated pneumonia, but does not reduce mortality in patients with acute respiratory failure and may increase the risk of other complications such as pressure ulcers [45, 46].

However, there still existed a growing body of clinical evidence supporting that prone position is of positive significance in delaying the progress of pulmonary diseases and improving prognosis. Compared with left lateral position, patients underwent thoracoscopic esophagectomy in the prone position had a markedly higher oxygenation index after the surgery, though no significance was found in the PPCs between the two surgical positions [47]. Prone position was proved to effectively reduce arterial partial pressure of carbon dioxide (PaCO₂), improve oxygenation index and SaO₂ in severe pneumonia patients [48]. Moreover, as one of the protective lung ventilation strategies, prone position could reduce mortality in severe ARDS and acute respiratory failure patients significantly [49–52]. When applicated to conscious patients, prone position manifested a similar outcome. Early APP combined with noninvasive ventilation or high-flow nasal canula could reduce or delay the need for intubation and the possibility to develop to critical patients in moderate to severe ARDS patients with COVID-19 [53, 54]. For acute hypoxia patients, APP was recommended to be carried out early to prevent the worsening of hypoxemia and respiratory failure [42].

Prone Position In Geriatric Patients With Hip Fracture

If there exists evidence in both anatomic physiology theory and clinical practice that prone position ventilation can improve pulmonary function, we believe that its application should not be limited to patients with severe ARDS. Whether pulmonary complications, which is common following fracture, can be prevented by prone position treatment arouses our interest. Unfortunately, so far, to the best of our knowledge, there have been no reports of the prone position treatment being used in orthopedic field. This trial is an attempt to extend the application of APP to postoperative management of geriatric patients with hip fracture in general ward and provide high-quality evidence.

We believe that postoperative APP treatment in elderly patients with hip fracture is feasible according to the following facts: 1. The only absolute contraindications for prone ventilation were unstable rib or spinal fractures [43]. 2. The development and maturity of anti-rotary intramedullary nail and hip joint arthroplasty technology realize the possibility of early pain relief and rehabilitation activities after hip fracture surgery. 3. No possible complications such as prosthesis dislocation and internal fixation failure occurred in 42 patients arranged in APP group in the preliminary trials. 4. Improving pulmonary function and physiological status via postural change better than relying on exogenous oxygen supplement. Moreover, Inappropriate exogenous oxygen supplementation could further damage alveolar type II epithelial cells and cause refractory hypoxemia and respiratory failure [55].

We choose to carry out APP treatment for the first three consecutive PODs to prevent PPCs for the following reasons: 1. The peak time for diagnosis of PPCs and hypoxemia occurred on POD 4 after hip fracture surgery in the elderly [10, 56]. 2. The early postoperative hyperinflammatory state would lead to ALI and increase the risk of pulmonary infection. Animal experiments have shown that elderly rats exhibited the highest pulmonary inflammation level histologically in the first three days following hip fracture fixation. 3. In this period, pulmonary infection risk and mortality rate of elderly rats receiving hip fracture fixation also reached a peak if inoculating in airway with Pseudomonas aeruginosa once surgery completed [57–60].

As reported, the duration of therapeutic prone position was at least up to 2 hours per day was considered to be effective [61]. However, as a preventive measure for PPCs, the suitable duration of APP is uncertain. According to our experience, the tolerance limitation for one time to keep prone position in the first 3 consecutive PODs for most patients receiving hip fracture surgery was not longer than 30 minutes. Furthermore, we have no indication to use sedative drugs for conscious patients in general ward to prolong the time in prone position as if in ICU, which is unethical. According to the preliminary trial results, there were significant differences in some outcome between the APP group and control group such as the difference value in PaO₂ between POD 4 and EV, and the incidence of PPCs within the first 30 PODs. If the results of the RCT prove the efficacy of postoperative APP in geriatric patients with hip fractures, this research could share our experience and help develop subsequent implementation procedures.

Trial Status

The trial opened to recruitment in September 2021 and will close to recruitment in December 2024 (protocol version 20230220).

ADL

Activities of daily living

ALI

Acute lung injury

APP

Awake prone position

ARDS

Acute respiratory distress syndrome

BMI

Body mass index

BNP

Brain natriuretic peptide

Covid-19

Coronavirus disease 2019

CPIS

Clinical pulmonary infection score

CRP

C-reaction protein

Computerized tomography

Emergency visits

FNF

Femoral neck fracture

FiO2

Fraction of the inspired oxygen

HHA

Hemiarthroplasty

IEC

Independent ethics committee

LOS

Length of stay

mMRC

modified British Medical Research Council

PaCO2

Arterial partial pressure of carbon dioxide

PaO2

arterial partial pressure of oxygen

P/F

PaO2/FiO2

PODs

Postoperative days

POP

Postoperative pneumonia

PPCs

Postoperative pulmonary complications

RCT

Randomized controlled trial

SaO2

Arterial oxygen saturation

SPIRIT

Standard Protocol:Items:Recommendations for Interventional Trials

THA

Total hip arthroplasty

T2DM

Type 2 Diabetes Mellitus.

Acknowledgements

Not applicable.

Authors’ contributors

YG conceived of the study and designed the first draft of the protocol. This author made substantial contributions to exploration for details of interventions such as timing, duration and suitable intervention process. This author also carried out preliminary experiment and confirmed the feasibility of the study. LS proposed the application of prone position for geriatric patients with hip fracture initially and made substantial contributions to revising the study design, modifications of the study to conform to guidelines and for logistics. YZ, MC, WG and TX made substantial contributions to the drafting and revising of the protocol. YL is the chief physician in geriatrics. This author substantial contributions to the diagnosis of postoperative complications for participants and the revising of the protocol. HC is one of the main surgeons and the head of the Orthopedics Trauma Institute who organizes the medical attendings managing the patients after surgery. This author made substantial contributions to the design of the work, planning of data analysis, drafting and revising of the protocol. YR is another main surgeon and the head of this series of researches. This author made substantial contributions to the design of the work, planning of data analysis, drafting and revising of the protocol, final approval of the version to be published and agrees to be accountable for all aspects of the work in ensuring that questions related to the accuracy of the work.

Funding

This protocol presents independent research funded by Jiangsu Provincial Geriatric Health Scientific Research Project (LKZ2022010). The funder had no further role in study design; data collection, management, analysis, or interpretation of data; writing of the report; or the decision to submit the report for publication.

Availability of data and materials

Access to the full protocol, trial dataset and statistical code will be made available upon request to the Chief Investigator. Updates will be available on the http://www.chictr.org.cn/ website.

Ethics approval and consent to participate

Independent ethics committee (IEC) for Clinical Research of Zhongda Hospital, Affiliated to Southeast University. All participants will provide written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Author details

¹Department of Orthopaedics, Zhongda Hospital, School of Medicine, Southeast University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, PR China.

²Orthopaedic Trauma Institute (OTI), Southeast University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, PR China.

³Trauma Center, Zhongda Hospital, School of Medicine, Southeast University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, PR China.

⁴Multidisciplinary Team (MDT) for Geriatric Hip Fracture Comprehensive Management, Zhongda Hospital, School of Medicine, Southeast University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, PR China.

⁵Department of Geriatrics, Zhongda Hospital, School of Medicine, Southeast

University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, PR China.

Protocol amendments: Any important protocol modifications will be communicated with investigators, REC / IRBs, trial participants, trial registries, journals and regulators.

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published 18 Apr, 2023

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Reviewers agreed at journal
04 Apr, 2023
Editor assigned by journal
27 Mar, 2023
First submitted to journal
03 Mar, 2023

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Postoperative awake prone position in geriatric patients with hip fracture: a protocol for a randomized controlled trial on the efficacy of postoperative prone position in reducing pulmonary complications and improving oxygenation

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Journal Publication

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Abstract

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Introduction

Objective

Method And Analysis

Overview of trial design

Primary Research Question

Secondary Research Question

Hypothesis

Setting And Participants

Results Of Pilot Study (Additional File 6, Just For Reviewer)

Data Collection And Analysis Plan

Patient And Public Involvement Subsection

Discussion

PPCs in geriatric patients with hip fracture

The Physiological Viewpoint Of Prone Position

Clinical Application Of Prone Position Treatment

Prone Position In Geriatric Patients With Hip Fracture

Trial Status

Abbreviations

Declarations

References

Supplementary Files

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Journal Publication

Version 1