Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty: study protocol for a randomized controlled trial

doi:10.21203/rs.3.rs-1519183/v1

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Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty: study protocol for a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-1519183/v1

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published 21 Jul, 2023

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• Background: More than 2 billion peripheral vascular cannulas are introduced globally each year. It is the most frequently performed invasive procedure in medicine worldwide. There is a group of patients with difficult intravenous access (DIVA). In experts’ hands, ultrasound guided vascular access appears to be a significantly better method. Investigators hypothesize that UGVA is superior also in short term patency of cannula and even for blood draw through cannula. Repeated cannula pricks in the operating room setting not only puts a lot of stress on patient and medical staff, they also waste OR time.

• Methods: This investigator-initiated prospective randomized monocentric controlled trial is designed to randomly allocate 400 patients undergoing elective primary total joint arthroplasty of hip or knee to one of two groups as follows: Group C (control group) – peripheral venous cannula insertion by palpation or Group USG (intervention) – cannula insertion by ultrasound guided vascular access. Our primary endpoint is to compare number of attempts for ultrasound guided insertion of peripheral venous cannula with common palpation insertion of peripheral venous cannula in overweight/obese patients (BMI ≥ 25). The secondary endpoint is failure rate of peripheral venous cannula to administer intravenous therapy up to 5 days postoperatively. Tertiary endpoints include portion of long PVCs that are able to ensure blood draw up to 5 days postoperatively, time needed to insert PVC in each group, number of needle tip redirections in both groups, reinsertion of PVC needed in both groups for any reason.

• Discussion: This study is pragmatic and is looking for clinically relevant data. After completion it will answer the question whether it is clinically relevant to use ultrasound guided vascular access in the context of not only short-term benefit of insertion, but also up to 5 days after insertion. Also, if this method can ensure blood draw through peripheral vein cannula, it can save resources in perioperative period - valuable especially considering the ongoing shortage of medical staff worldwide. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of ultrasound guided peripheral vascular access in perioperative period.

Trial registration: Registered on clinicaltrials.gov 13.12.2021 under CT number: NCT05156008

Vein Cannulation

Peripheral venous access

Long cannula

Ultrasound guided vascular access

Randomized trial

Note

the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).

Title {1}	Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty: study protocol for a randomized controlled trial
Trial registration {2a and 2b}.	clinicaltrials.gov, under CT number: NCT05156008
Protocol version {3}	version 4.0 (Feb. 16, 2022) of the original protocol
Funding {4}	No funding
Author details {5a}	¹ Department of Anaesthesia and Intensive Care, Slovak Medical University, F. D. Roosevelt University Hospital, Banska Bystrica, Slovakia ² Department of Biology & Ecology, Faculty of Natural Sciences, Matej Bel University, Banska Bystrica, Slovakia ³ Institute of Anatomy, Faculty of Medicine, Comenius University Bratislava, Slovakia ⁴ Orthopedic Department, Slovak Medical University, F. D. Roosevelt University Hospital, Banska Bystrica, Slovakia
Name and contact information for the trial sponsor {5b}	F. D. Roosevelt University Hospital Banska Bystrica, Slovakia, Nám. L. Svobodu 1, Banska Bysrica, Slovakia.
Role of sponsor {5c}	Legal responsibility, provides facilities and medical staff.

Background and rationale {6a}

There is a group of patients with difficult intravenous access (DIVA). In experts’ hands, ultrasound guided vascular access appears to be a significantly better method. Investigators hypothesize that UGVA is superior also in short term patency of cannula up to 5 days and even for blood draw through cannula. In overweight/obese orthopedic patients the DIVA subpopulation can reach up to 50%.^5,6 Ultrasound seems to facilitate vascular access in patients with higher BMI.¹¹ The classic landmark technique becomes very difficult in the higher BMI ranges, whereas ultrasound is mostly unaffected by BMI. In our hospital we perform over 1.000 joint arthroplasties annually. In a small internal hospital audit (n = 34) we found out that 60% of inserted cannulas that adhered to strict insertion protocol (figure 1) under ultrasound, ensured blood draw on POD (Post Operative Day) 1 and 2. If we can insert a low cost long PVC that can last up to 5 days and allows for blood drawing, it will ease the perioperative period for DIVA patients and medical staff as well. To the best of our knowledge, no randomized controlled trials have yet been performed to study the effect of ultrasound guided vascular access of long PVCs in orthopedic overweight patients with focus on i.v. access patency up to 5 days and ability to draw blood through PVC. Ultrasound can reduce number of attempts and complications as well, but only in the experienced hands of a fully trained UGVA specialist. Repeated cannula insertions not only put a lot of stress on patient and medical staff. They also waste OR (operating room) time and use up the veins of the patient, which may never heal and this makes vein punctures even more difficult in the future.

Objectives {7}

The primary objective of this investigator-initiated prospective randomized controlled trial is to compare number of attempts for ultrasound guided insertion of PVC with common palpation insertion of PVC in overweight/obese patients. The secondary objective is comparison of long PVCs and “regular” short PVCs in terms of their ability to administer intravenous therapy through the cannula up to 5 days postoperatively. Tertiary objectives are portion of long PVCs that are able to ensure blood draw up to 5 days postoperatively, time needed to insert PVC in each group, number of needle tip redirections in both groups, reinsertion of PVC needed in both groups for any reason.

Trial design {8}

This investigator-initiated prospective randomized monocentric controlled trial is designed to enroll 400 patients. The study is being performed in accordance with the Declaration of Helsinki (The Revised Declaration of Geneva: A Modern-Day Physician’s Pledge, 2017)¹², Good Clinical Practice (GCP) guidelines and SPIRIT protocol for randomized trials¹⁴. The study has been approved by the local ethics committee (protocol number: 26/2021) at F. D. Roosevelt University Hospital in Banska Bystrica, Slovakia. The trial has been prospectively registered at https://www.clinicaltrials.gov (reference: NCT05156008) and will be monitored by the ethical committee of F. D. Roosevelt University Hospital.

Study setting {9}

This study is conducted in single center, in the clinical settings of the Orthopaedic Department of F. D. Roosevelt University Hospital and Operating Rooms by medical staff of Anesthesia and Intensive Care Department of F. D. Roosevelt University Hospital.

Eligibility criteria {10}

Inclusion criteria are: (1) age group of 18–75 years, (2) body mass index > 25, and (3) primary hip or knee arthroplasty. Exclusion criteria are as follows: (1) reoperation of arthroplasty, (2) mental disorder, (3) sepsis, (4) protocol non-compliance, (5) pregnancy, and (6) patient refusal or no informed consent or both. Interventions are performed by anesthestists trained in UGVA.

Who will take informed consent? {26a}

Patients scheduled for elective primary total joint arthroplasty of hip or knee surgery in F. D. Roosevelt University Hospital in Banska Bystrica, Slovakia will be asked for written informed consent by a member of the Anesthesiology or Orthopedics Department during preoperative assessment.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

Not applicable, we do not want to use data in another study. No specimens are collected.

Interventions

Explanation for the choice of comparators {6b}

Classic palpation approach for vascular access is challenging in DIVA patients. Up to 50% of orthopedic patients are DIVA (5,6) and orthopedic surgeries are on the rise in developed countries. Medical staff can site venous cannula only to veins they can see. Therefore, the cannula is often in a suboptimal place of flexion of the arm in the wrist or elbow which are associated with complications (7).

Ultrasound enables us to place cannula in an ideal place, in terms of complications mentioned above. In addition, we can measure diameter of vein and use cannula width that will obscure only one third of internal lumen. This should allow for blood draw because of undisturbed blood stream in the vein.

We chose UGVA approach in comparison to classic palpation approach in standard clinical settings. This design of study allows to compare standard of care (insertion of cannula by palpation) to the modern (ultrasound guided insertion of cannula), technically more challenging but also more rewarding option.

Intervention description {11a}
All patients in the ultrasound group will receive a prick by an UGVA experienced physician in the block room, preoperatively. The time measurement starts with prescan of the forearm and then, if no suitable vein is found, the anesthetist will prescan the upper arm. Under strict antiseptic precautions, after preparation of skin with 2% Chlorhexidine (Chlorhexidine, BBraun, Germany) and sterile cover of probe Dermafoil (Dermafoil, Batist, Czech Republic), introduction of cannula is carried out by anesthetist. The entire procedure follows our study protocol, using out of plane technique with constant clear visualization of needle tip, which is slowly advanced all the way into the vein. The procedure may be performed with or without tourniquet following insertion manual (figure 1). Another researcher makes notes into the study protocol (figure 2).

Criteria for discontinuing or modifying allocated interventions {11b}

All patients in the control group will receive prick with palpation by an experienced nurse or anesthetist in block room, preoperatively. Time measurement starts when nurse or anesthetist puts tourniquet on or starts to look for suitable vein on the forearms. If no suitable vein is found on the forearms, we will switch to ultrasound. Under strict antiseptic precautions, after preparation of skin with 2% Chlorhexidine (Chlorhexidine, BBraun, Germany), introduction of cannula is carried out by a nurse or anesthetist. After two unsuccessful pricks the operator must switch to ultrasound or call an experienced UGVA anesthetist. Another researcher makes notes into the study protocol (figure 2)

Strategies to improve adherence to interventions {11c}

Adherence is going to be high because many of these patients are DIVA. We have 3 ultrasound machines dedicated to operating area. Many anesthetists and some anesthesia nurses are trained in UGVA. Therefore, there should always be UGVA trained personal and USG machine readily available.

Relevant concomitant care permitted or prohibited during the trial {11d}

Prohibited concomitant care is: application of vesicants or irritants infusions through peripheral vein cannula. Allowed concomitant care is: antibiotics therapy that are not vesicants or irritants.
Provisions for post-trial care {30}

The sponsor has insurance, which is in accordance with the legal requirements in the Slovakia. There is not ancillary care. Only common, well-known complications can occur in relation to peripheral vascular access.

Outcomes {12}

The primary and secondary outcomes will be evaluated using the χ² test in terms of the difference in approaches of cannula insertion between groups in the number of punctures and the failure rate of the cannulas (failure rate is defined as the proportion of cannulas requiring reinsertion within 5 days after insertion). RR and 95% confidence interval of successful venous cannulation will be also calculated. The primary endpoint is number of attempts to successful cannulation determined by number of skin punctures. More attempts are associated with complications. As a secondary endpoint, failure rate is calculated from ratio of cannulas that did not fail to cannulas that failed for any reason in each group, up to the first 5 days postoperatively. This data is obtained from the patient protocol (figure 2). Primary and secondary outcomes will be reported as frequencies and percentages. For our tertiary outcome, to compare differences between the intervention groups (time required for cannula insertion, number of cannulas used, A-DIVA scoring system, etc.), t-test for independent groups or Mann-Whitney U test will be used, if data are not normally distributed. The effect of the intervention on outcome variables will be determined by using paired t-test or Wilcoxon signed-rank test for data obtained at baseline and for 5 days of the study. Other endpoints include portion of long PVCs that are able to ensure blood draw up to 5 days postoperatively, time needed to insert PVC in each group, reinsertion of PVC needed in both groups for any reason. All this data is recorded in the study protocol.
Participant timeline {13}

	STUDY PERIOD
	Enrolment	List of patient time period	Allocation	Post allocation		Close out
Timepoint	D -1	D – X	0	D1	D 2 – 4	D5
ENROLMENT:
Eligibility screen	X
Informed consent	X
Randomization		X
Allocation			X
INTERVENTIONS:
Group C				X
Group USG				X
ASSESSMENTS:
Baseline variables				X
Primary outcome				X
Secondary outcome					X	X
Tertiary outcome					X	X

Sample size {14}

The estimate for final sample size was based on the expected drop-out rate, and the objective and design of the study. This trial assumes a comparison of the effect on outcome variables in peripheral vein insertion in the USG group and palpation-inserted peripheral venous cannula as control group. In overall, we hypothesize that it will take fewer attempts to insert the cannula into a vein with USG technique (USG: 1 vs. C: 1–3), corresponding to a reduction in time of ³ 3 minutes (clinically relevant indicator) for successful cannulation in the USG group. When calculating the sample size, based on our experience and literature data, we assumed a 20% risk of complications inserting the cannula into a vein in the standard way, 5% as a probability of a Type I error (α <0.05), and the power of the test 90% (β=0.10). Theoretically, we also accepted a 5% risk failure of a first insertion of cannula into a vein in the USG group. The sample size calculation was based on the result of the risk ratio (RR) between groups as % of complications (unsuccessful prick) with cannula insertion into the peripheral veins¹³. The adequate sample size of 162 patients was calculated as described previously ¹⁴, increased by 20% for the case unforeseeable circumstances (technical error, data loss, poor patient cooperation, etc.) and rounded @ 200.

Recruitment {15}

The study will include all patients who are indicated for surgery at the time of the registration period and who have met the agreed inclusion criteria. Under the sponsor’s supervision, investigators initiate patients’ enrollment. In our institution, 1.000 arthroplasties are performed annually. The intervention is low cost and necessary to conduct surgery.

Assignment of interventions: allocation

Sequence generation {16a}

Patients are included in the group on an ongoing basis, in the order in which they were identified. Every month a certain number of patients is planned for surgery. Every patient is assigned a random number using the randomization function in SPSS software v. 20.0 (IBM SPSS, Armonk, NY), and subsequently randomly generated in the same program in a ratio of 1: 1 into intervention USG group (insertion of the cannula under ultrasound control) and control group (palpation and direct visualization for cannula insertion). Nevertheless, comparisons of demographic and baseline characteristics between the treatment groups will be conducted to control the effectiveness of randomization. Assignment of patients to the appropriate group will be stored in an envelope that will not be opened until the day of the operation. The proposed study has a single blinded design. On the day of surgery, in the block room, the anesthetist will open envelope and find out the allocation of the patient. According to patient allocation, medical staff will perform the procedure in accordance with the study protocol. This procedure will be repeated until target sample size is reached.

Concealment mechanism {16b}

Only one employee working with randomization has knowledge about patient allocation. Each patient allocation is in a sealed opaque envelope. On the day of surgery, in the block room, the anesthetist will open envelope and find out the allocation of the patient. According to patient allocation, medical staff will perform the procedure in accordance with the study protocol.

Implementation {16c}

Allocation sequence will be generated by SPSS. Participant enrollment is up to the anesthetists and orthopedic surgeons. Allocation is not concealed and will be revealed to both the patient and the researcher upon randomization.

Assignment of interventions: Blinding

Who will be blinded {17a}

It is almost impossible to blind care providers or patients because of different appearance of cannulas and different fixation of device. There is no blinding.
Procedure for unblinding if needed {17b}

Not applicable. There is no blinding.

Data collection and management

Plans for assessment and collection of outcomes {18a}

Written protocol (in paper) provides systematic measurements that assessor has to collect. All assessors will attend compulsory training how to carry out every step in the study. All study related documents are on cloud that can be accessed by study personnel.

Plans to promote participant retention and complete follow-up {18b}

Participants are studied only up to 5 days or discharge from hospital, whichever comes first. The study doesn’t require any extra actions or active collaboration from patients. If the patient deviates from intervention protocols, we will use data of patient up to timepoint of deviation if eligible; if not, the patient will be excluded. Exclusion probability is low due to short period of observation and low to none patient active collaboration.

Data management {19}

Every patient will get a numerical code instead of his real data or name on enrollment. Only these codes will be used throughout the study. All emails exchanged between researchers including patients or study data have to use hospital servers only. In addition, every file will be password protected. Hospital standards for data management will be used, every employee is familiar with those. In addition, during the assessors’ training, time will be allocated for data management.

Confidentiality {27}

As mentioned above (SPIRIT 19) Every patient will get code instead of name in enrollment process. This data can be shared among researchers only through hospital servers and emails. All files, with patient or study data, have to be password protected.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Not applicable. No samples collected.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}

Interim analyses {21b}

There is very low risk of complications associated with peripheral venous access. Venous access is essential for every patient in perioperative period. Our intervention doesn’t impose any additional risk to the patient. Investigators are obligated to report any adverse event to the ethical committee. Chief of ethical committee Dr. Stricova has final decision to terminate the trial.

Methods for additional analyses (e.g. subgroup analyses) {20b}

When studying with several groups, we will combine these groups appropriately; in other words, we will analyze different intervention versus control subgroups and create simple pairwise comparisons using the same statistical analysis methods that have already been described for categorical or metric (continuous) quantities in the "Data collection and statistical methods" section.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Not all processes set up in the study deviate from the design of the randomized controlled clinical trial. When analyzing data, if any qualitative or metric data is found, we will first contact a team member who records or measures the data to supplement the missing data, if at all possible, while analyzing the reasons why the data is missing. We will use all available SPSS applications to check / analyze data completeness. In addition, SPSS statistical programs can evaluate and process incomplete data sets correctly (each analysis uses only cases without missing values for all variables and for all analyzes). Therefore, we will not artificially attribute any missing values and we will take into account the missing data in the interpretation of the results. Patients with a large amount of missing data will be excluded from the final statistical analysis.

Plans to give access to the full protocol, participant level-data and statistical code {31c}

The datasets used and/or analyzed during the current study can be made available by the corresponding author upon reasonable request and in agreement with the research collaboration and hospital data transfer guidelines.

Oversight and monitoring

Composition of the coordinating centre and trial steering committee {5d}

This is a monocenter study designed, performed and coordinated in the FDR University Hospital in Banska Bystrica, Slovakia. Day to day support for the trial is provided by: Principle investigator: takes supervision of the trial and medical responsibility of the patients. Data manager: organizes data capture, safeguards quality and data. Study coordinator: trial registration, coordinates study visits, annual safety reports. Study physician: identifies potential recruits, takes informed consent, ensures follow-up according to protocol. The study team meets once per month or more often if situation demands that. There is no trial steering committee or stakeholder and public involvement group. Online or in person as situation demands.

Composition of the data monitoring committee, its role and reporting structure {21a}

DMC is not needed. this is not a blinded study, there is no DMC required to protect blinding of the researchers and physicians.

Adverse event reporting and harms {22}

All adverse events reported by the subject or observed by the investigators will be recorded. The causality to the study treatment event will be recorded. Investigators have to report any adverse events to ethical committee. We use hospital email addresses every employee has on this purpose. All adverse events are collected by principal investigator.

Frequency and plans for auditing trial conduct {23}

There is authorized personnel for auditing trial conduct, the process is independent from the sponsor Also Health Care authorities can take place in auditing like Slovak Healthcare Surveillance Authority.

Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}

If anything, important changes in the study protocol we will reflect that change in the clinicaltrials.gov registry and notify the ethical committee.

Dissemination plans {31a}

The study will be published in a peer reviewed journal..

Ultrasound guided vascular access is essential skill in modern anesthesia practice. It is recognized also by medical faculties, therefore in some countries they include this skill into student’s curriculum. In the beginning of training, it is time consuming although as operator gets enough practice whole insertion process takes only seconds. This is biggest challenge. To ensure that there is always physician/nurse that is proficient in UGVA.

LIMITATIONS

In order to obtain relevant data, it is necessary to ensure vascular access in both groups by experienced and professionally trained staff. Otherwise, there might be misleading data through the whole study.

DIVA is a widespread problem in many patient groups. We chose orthopedic patients scheduled for total hip- or knee- arthroplasty due to a relatively similar patient population, high patient turnover, higher rates of obesity (which is an inclusion criterion) and most importantly, the electivity of the procedure.

The difference between the types of needle/cannula used in the classic method and the USG method reflects both the different nature of the veins being cannulated (superficial vs. deep), as well as the clinical practice in our institution.

STRENGHTS

“Classical” Vasofix needles used in the control group are widely and routinely used by our staff when cannulating veins preoperatively. Deep Introcan needles are in turn used in sonography due to the longer length of the needle required to reach the deeper veins in the forearm and upper arm. Thus, we are comparing the gold standard of the classic method with the gold standard of the USG method. If we would use the same needle in both groups, one group would necessarily receive inferior care – biasing our results and potentially damaging our patients. Study is also focused on not just vascular access obtaining but also on vascular access durability in relation to UGVA. UGVA allows to choose better place to site peripheral vein cannula in comparison with palpation technique which might translate in to lower complication rates. All of these measurements have great impact on how long this low-cost cannula lasts in DIVA patient.

The choice of our outcomes is a comprehensive list of all the potential benefits of USG cannulation: reducing number of patient pricks for needle insertions and blood draws – increasing satisfaction and reducing complications; reducing time spent in the OR to facilitate increased patient turnover; using less material and saving manpower – making it an economical procedure.
Trial status

This document is based on version 4 (Jan. 16, 2022) of the original protocol. We anticipate randomly assigning the first patient on April 1st, 2022, and plan to complete the study in October 2023.

Acknowledgements

Not applicable

Authors' contributions

See 31b

Funding

No funding provided

Availability of data and material

Datasheets will be publicly available on clinicaltrials.gov

Ethics approval and consent to participate

See English translation in additional documentation on submission or we will provide on request

Consent for publication

Not applicable. No patients’ pictures or any other information provided

Competing interests

All authors declare no competing interests

Acknowledgements

Not applicable.

Authors’ contributions {31b}

JH is chief Investigator; he conceived the study, led the proposal and protocol development. AR is the lead trial methodologist. MV contributed to study design and protocol proposal. IG and MH contributed with protocol revision, text revision. MTG contributed to protocol proposal, text revision and grammar correction. All authors read and approved the final manuscript.

Funding {4}

Not applicable, no funding.

Availability of data and materials {29}

All data will be publicly available on clinicaltrials.gov.

Ethics approval and consent to participate {24}

Ethical committee granted this study under protocol: Ethical Review Board, protocol No. 26/2021. Written, informed consent to participate will be obtained from all participant’s prior study.

Consent for publication {32}

Consent form consist of four pages. We are willing to provide consent form on request.

Competing interests {28}

All authors declare that they have no competing interests.

Authors’ information (optional)

Jakub Hlasny, MD, EDRA is anaesthetist consultant in F. D. Roosevelt University Hospital and clinical lead in regional anaesthesia and vascular access. EDRA examiner and member of ESRA, SKARA.

Roman Alberty, Associate Professor of Biology at the Department of Biology and Ecology, Matej Bel University. He deals with methodology and practical statistics for medical research.

Marian Hlavac, MD, PhD.

Michael T Grey, MD. Anaesthetist resident in F.D. Roosevelt University Hospital.

Michal Venglarcik, MD, PhD. Deputy chief of anaesthesia in F. D. Roosevelt University Hospital, he laid the foundations for regional anesthesia and ultrasound utilization in anesthesia and intensive care in FDR University Hospital. Pain medicine specialist. Member ESRA, SSSLB, vice president of SKARA.

This document is based on version 4 (Feb. 16, 2022) of the original protocol. We anticipate randomly assigning the first patient on April 1st, 2022, and plan to complete the study in October 2023. The trial results will be submitted to a peer-reviewed journal regardless of the outcome.

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Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty: study protocol for a randomized controlled trial

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