Mechanical Hyperinflation Maneuver and intracranial pressure of critical neurological patients: protocol for a randomized clinical trial.

doi:10.21203/rs.3.rs-1336237/v1

Background: Mechanical Hyperinflation Maneuver (MHM) is a technique known for optimizing bronchial hygiene and respiratory mechanics, however its effects on intracranial pressure are not known.

Methods: 48 patients aged ≥ 18 years, with clinical diagnosis of acute stroke, confirmed by neuroimaging examination, with onset of symptoms within 72 hours, under mechanical ventilation through tracheal tube, will participate in this study. Participants will be randomly allocated into 2 groups: Experimental Group (n=24): MHM plus tracheal aspiration, and Control Group (n=24): tracheal aspiration only. Intracranial pressure will be measured by a non-invasive technique using Brain4care BcMM-R-2000 sensor. This will be the primary outcome. Results will be recorded at 5 times: T0 (start of monitoring), T1 (moment before MHM), T2 (moment after the MHM and before tracheal aspiration), T3 (moment after tracheal aspiration), T4 and T5 (monitoring 10 and 20 minutes after T3). Secondary outcomes are respiratory mechanics and hemodynamic parameters.

Discussion: This study will be the first clinical trial to examine the effects and safety of MHM on intracranial pressure measured by non-invasive monitoring. Limitation includes the impossibility of blinding the physical therapist who will supervise the interventions. It is expected with this study to demonstrate that MHM can improve respiratory mechanics and hemodynamic parameters, and provide a safe intervention with no changes in intracranial pressure in stroke patients.

Trial registration: Brazilian Clinical Trial Registry (RBR – 5qs9k2n). Registered on 27 July 2021. https://ensaiosclinicos.gov.br/rg/RBR-5qs9k2n

Protocol version 1.0, protocol date March, 2019.

Mechanical ventilators

stroke

intracranial pressure

respiratory mechanics

physical therapy techniques

Neurocritical patients with acute neurological impairment, especially stroke, often require the use of mechanical ventilation (MV) (1, 2), either by lowering of the level of consciousness (due to lesion in the thalamus, limbic system, reticular formation in the brainstem), protection of the airways (brainstem), or respiratory control (respiratory center in the cortex, bulb, and pons) (3).

Prolonged MV dependence associated with brain-lung crosstalk and immunosuppression induced by ischemic event (2, 4, 5) can increase the retention of lung secretions and lead to pulmonary complications with an underlying higher risk of death (2).

Evidence corroborates the benefits of using strategies for the removal of secretion associated with MV (6, 7), including MHM, which has been widely applied and discussed (8, 9). However, hyperinflation causes higher intrathoracic pressure (ITP), which can influence cardiac output (CO), mean arterial pressure (MAP), and Intracranial pressure (ICP) (10), thus compromising the indication of this technique. Even though some studies have demonstrated cardiovascular stability during MHM (11, 12), no studies have addressed the monitoring of intracranial compliance (ICC) during and after the maneuver performance in critical neurological patients. This possibly occurs due to the barrier imposed by the invasive method involving skull trepanning and insertion of a catheter in the cranium, required for monitoring the ICP in traditional methods (13). Although the technique of inserting a cerebral catheter is the gold standard and most recognized measure for ICP monitoring, the exigence of surgical intervention, training, and specific interpretation technique make it financially unviable for studies at Intensive Care Units (ICUs) on a small and large scale.

Over the past few years, a new instrument has been proposed for non-invasive monitoring of ICC through a sensor capable to detect bone malformations derived from ICP variation (14, 15), which allowed to monitor these patients, which enabled the monitoring of these patients, called Brain4care (B4C) sensor.

The B4C technology allows analyzing the ICC waveform, by the relationship between the peaks of ICP, P1, P2 and P3. ICC is characterized by the relationship between the volumes of intracranial components (brain, cerebrospinal fluid and blood). The loss of hemostasis between these components is related to a substantial increase in ICP (15).

In this context, considering the need to perform MV in critical neurological patients, as well as the retention and need for effective, safe removal of lung secretions and related clinical impact on ICP variation, our objective was to develop an MHM protocol and investigate its effects on ICP and ventilation mechanics on patients with stroke.

Trial design

The protocol meets a randomized clinical trial approved by the Research Ethics Committee of the Clinical Hospital at the Federal University of Paraná (CAAE: 01378118.7.0000.0096). The individuals are allocated through simple randomization into two groups. All items in the Data Set of the Register of Tests by the WHO were recorded on the database of the Brazilian Clinical Trial Registry (RBR – 5qs9k2n). Any alteration in the protocol is informed to the above-mentioned bodies. When preparing this protocol, we used the SPIRIT reporting guidelines (16) and a table with the standard protocol items (SPIRIT) is presented in Table 1. The SPIRIT checklist is available as an additional file (Additional file ).

Table 1

– Time schedule of enrolment, interventions, assessments, and visits for participants according to Recommendations for Interventional Trials (SPIRIT).
		STUDY PERIOD
		Enrolment	Allocation	Post -allocation		Close-out
TIMEPOINT		-t1	0	T1 Baseline	T2 Intervention	T3 Post 8 weeks
ENROLMENT
Eligibility screen		X
Informed consent		X
Allocation			X
INTERVENTIONS:
Control Group					X
Experimental group					X
OUTCOMES VARIABLES
Background information
Socio-demographic and clinical characteristics		X				X
Primary outcome measures -
Intracranial Compliance	Relation P2/P1			X		X
	Inclination P1 - TTP			X		X
	Classification P1			X		X
Secwavery outcomes measures
Lung Mechanics	Static Compliance			X		X
	Dynamic Compliance			X		X
	Resistance			X		X
	Expired Current Volume			X		X
Hemodynamic Stability	MAP			X		X
	HR			X		X
	SpO2			X		X
TTP: time to peak; MAP: Mean Arterial Pressure; HR: Heart Rate; SpO₂: Peripheral Oxygen Saturation.

Setting and Participants

Information and guidelines on this research (objectives, methodology, risks, and benefits) are given to critical neurological patients admitted to ICU at the Clinical Hospital Complex of the Federal University of Paraná and met the inclusion criteria. Their inclusion in the study is effective by agreeing to participate and signing an Informed Consent (IC), according to Resolution 466/2012 by the National Health Council. In the case of patients unable to respond for themselves, their legal representatives are approached. After recruitment and IC signature, data collection is initiated.

Individuals with acute stroke diagnosis are included in the study upon neuroimage exam confirmation, with symptoms dating back to 72 hours, under MV through a tracheal tube, both male and female and over the age of 18, whose relatives signed the IC. Exclusion criteria included individuals who received contraindication for the enhancement of positive ITP (pneumothorax, hemothorax, and acute respiratory distress syndrome), presented peak pressure (Ppeak) > 40 cmH2O in the MV, patients with Richmond Agitation-Sedation Scale (RASS) above − 3 (asynchronicity in MV and difficulty in coupling to the ICP monitoring sensor), patients with hemodynamic instability according to higher concentrations of vasoactive amines over the last 12 hours, and those who had been subjected decompressive craniectomy.

To control possible confusing factors regarding ICP increase, we will assess and monitor the level of carbon gas (CO2) exhaled – End Tidal CO₂ (ETCO₂) and pain throughout the data collection. ETCO₂ assessment is performed using a capnograph (Dräger Vamos@ plus monitor), whose sensors are calibrated two hours before the collection period and alarms, reference measures, and oxygen compensation adjusted (2). Pain is assessed according to the Behavioral Pain Scale, and the evaluation tool focused on behavioral indicators of pain previously translated and adapted to Portuguese (17, 18). All researchers were properly trained for data collection.

Randomization and Allocation Concealment

The participants are randomly distributed in the groups through a simple randomization procedure (random numbers generated by a specific software). Allocation concealment in the groups is conducted by using sequentially numbered and sealed opaque envelopes that are opened upon reviewing the IC. These procedures are performed by an independent physiotherapist.

Interventions

After the assessments, the selected patients are randomly allocated into two groups (Fig. 1): experimental group (EG) – composed of individuals who will be subjected to MHM + tracheal aspiration and control group (CG) – only tracheal aspiration intervention. All individuals will be positioned on dorsal decubitus at the bedside at 30°; MV is adjusted on assisted ventilation mode, controlling volume, tidel volume (Vt) of 6 ml/Kg of predicted weight, positive expiratory-end pressure (PEEP) 8 cmH₂0, inspired oxygen fraction (FIO₂₎ peripheral oxygen saturation (SpO₂) of 94%, and respiratory rate (RR), and flow (V) adjusted to maintain ventilation synchrony and gasometric demands. We will use a number 14 closed aspiration system with verified cuff pressure and the occurrence of leaks. All participants will be subjected to tracheal aspiration and only 2 hours later the data collection is initiated (Fig. 2). During these two hours, patients will only be monitored and maintained on the initial position, no concomitant procedures or disconnection of MV circuit are conducted. In case it is not possible to maintain such conditions, the collection is suspended and started again at the appropriate moment.

Assessments will range five stages: T0 (monitoring start), T1 (before ventilation maneuver for the intervention or control groups), T2 (end of ventilation maneuver our control), T3 (after tracheal aspiration), T4/T5 (monitoring after 10 and 20 minutes of procedure). The five initial minutes are required for the initial collection of hemodynamic, ventilation, and neurological data. After the start of this period, T1 with a 10-minute duration, followed by T2 and T3, with a five-minute duration each. The individuals in T1 who constituted the MHM group will have their ventilation parameters altered for 10 minutes according to the lung hyperinflation maneuver adopted, subsequently returning to the baseline values. During this period, the individuals in the control group will be only monitored. In T2, both groups will be subjected to tracheal aspiration, subsequently, data will be monitored for five minutes. Finally, the individuals of both groups were monitored at T4 and T5, 10 and 20 minutes after the procedure, respectively, to verify vital data stabilization (Fig. 2).

Experimental Group

We will perform ventilation adjustments to proceed with the MHM. The patient will be maintained on dorsal decubitus at the bedside at 30°, on assisted ventilation mode, and controlled volume. Vt will be increased by 150% based on ideal tidal volume; square wave V; inspiratory time (Ti) equal to 1.5 seconds, adjusted to a peak of inspiratory flow (PIF) lower than the peak of expiratory flow (PEF); RR of 14 irpm, reduced in case of auto-PEEP; PEEP 8 cmH₂O; FIO₂ minimum of SpO₂ of at least 94%. These parameters will be preserved for 10 minutes. The MV alarms will be adjusted to allow the safety of the maneuver, in addition, in case of Ppeak above 40 cmH₂O or plateau pressure (Pplateau) above 30 cmH₂O, the maneuver is immediately interrupted and the previous parameters reestablished. The hyperinflation maneuver will not be associated with any other bronchial hygiene maneuver.

After 10 minutes, the recommendations of the American Association for Respiratory Care (19) (2010) will be applied in the aspiration procedure, suggesting that the patients are ventilated with FIO₂ at 100% for 30 seconds before and 60 seconds after the procedure to avoid hypoxemia. In this study, each patient will be subjected to tracheal aspiration for 15 seconds for three consecutive times through a closed aspiration system with catheter number 14. Subsequently, the ventilation parameters will be readjusted according to the initial parameters.

Control Group

The ventilation parameters of the CG will only be placed and aspired following the same procedure adopted for the group intervention and will not be altered, in addition to being subjected to non-invasive monitoring of ICP at the same time points as in the EG.

Safety assessment and adverse effects

The vital signs (heart rate (HR), RR, MAP, and SpO₂) will be assessed continuously and registered during the assessment stages through a multiparameter monitor Mindray iMEC12, while Capnography will be assessed through a monitor and sensor Dräger Vamos®. Criteria for interrupting the intervention are HR < 60 bpm, Systolic Blood Pressure > 180mmHg, and Diastolic Blood Pressure < 50mmHg. The ICP assessed in a non-invasive manner will also be monitored during all procedures and 20 minutes after the end of the collections. The MV alarms will be adjusted to allow to control the airway pressures.

An expert physiotherapist will be present throughout the collection, and in case of hemodynamic and/or neurological instability, as well as an increase in airway pressures above the allowed values, the collection will be suspended, and a physician of the ICU staff will join the procedure.

Outcome Measures

Primary outcomes will consist of the alterations in ICC indicated in the morphology analysis of the ICP wave due to the MHM since in critical neurological patients, it is crucial to control the secondary lesion and complications caused by the need for MV. Secondary outcomes will range from lung mechanics and hemodynamic stability.

Primary Outcome

Intracranial Compliance

The ICP of all participant patients will be measured in a non-invasive manner through the sensor in the ICP equipment B4C BcMM-R-2000, acquired through funding by the National Council of Research. The researchers were trained by the B4C company and are prepared for data collection. To proceed with the monitoring, a sensor is installed by the researcher coupled to the scalp using an elastic band, without requiring any prior preparation or trichotomy.

The sensor is coupled through wires to a monitor that generates a curve and real-time display of ICP wave, in addition to recording the data for further analysis, which is enabled by extensometers capturing the intracranial volume expansions, since the cranial bone is not entirely hard. Therefore, the pulses are converted into numerical data forming the ICP curve morphology in real time (20).

The ICP wave morphology has its layout, such as in the case of the arterial pulse wave, with a total of up to five distinct peaks, of which three are proper and frequent: percussion wave (P1), tidal wave (P2), and dichroic wave (P3). P1 wave is the most constant in amplitude and derives from the pulse of large cerebral arteries to the choroid plexus. P2 wave, in turn, originates from the cerebral elastance direct reflecting the “reverberation” of P1 on both the brain and cranium, that is, ICC. Finally, the P3 wave is separated from P2 by the dicrotic notch corresponding to the closure of the cardiac aortic valve (21).

The data collected using this sensor are qualitative, which means that ICP has no absolute value; however, it is possible to analyze the morphology of this pressure curve by extracting three values: P2/P1 relation, P1 inclination (by the TTP value – time to peak), and P1 classification. The analysis of such morphology allows recognizing alterations in the ICP, and consequent decrease in ICC, since in scenarios of normality, the morphology of P1 > P2, and in scenarios of ICP P2 > P1 enhance (22).

Data will be collected through a monitor and analyzed using the Brain4care Analytics System, considering that at a time interval, the software selects an average of pulses to form the waves.

To capture the data, the ICP assessment sensor will be chosen according to the cranial circumference (S, M, L, XL) considering as protocol the lowest sensor possible with reading, following the manufacturer's recommendations. Data collection will start after the coupling procedure and confirmation by the assessor of reading compatible with the acceptable ICP curves.

Secondary Outcomes

Respiratory Mechanics

Respiratory mechanics is calculated at all times and for both groups by measuring the variables provided by the MV, which will allow inferring indirectly the efficiency of the maneuvers in promoting bronchial hygiene (7, 8).

The MV parameters will be adjusted according to the predicted weight for each patient (23). Patients will be ventilated on the volume-controlled assisted mode. The following variables will be recorded: programmed parameters (Vt, PEEP, RR, V, FIO₂) and variables related to respiratory mechanics [Ppeak, Pplateau, drive pressure, expired current volume, PIF, PEF], which along with the programmed parameters will be applied to calculate Resistance (Re), Static compliance (StaC), and Dynamic compliance (DynC) (24).

StatC, DynC, and Re are clinical variables often used to assess the therapeutic effects of the bronchial hygiene maneuvers (7, 8, 25). Such effect is possibly related to the recruitment of collapsed lung areas, increase in collateral ventilation, lung areas with a high time constant, and removal of secretions (8).

This protocol will use the following mathematical equations:

1. Predicted body weight

Male: 50 + 0.91 x (height in centimeters – 152.4)
Female: 45.5 + 0.91 x (height in centimeters – 152.4)

2. Resistance (Re)

Re = (Ppeak – Pplateau) / V

3. Static compliance (StaC)

StaC = VT / (Pplateau – PEEP)

4. Dynamic compliance (DynC)

DynC = VT / (Ppeak – PEEP)

We will follow a method of flow interruption at the end of the inspiration with a pause of three seconds to calculate the lung mechanics. Three measures will be performed using the average of the two measures with the lowest standard deviation. Upon absence of plateau, the measure will be disregarded (8).

Hemodynamic Stability

The variables of MAP, HR, and SpO₂ are used in intensive care to assess the hemodynamic impact of respiratory physiotherapy maneuvers (8).

For MAP and HR, we will consider as significant alterations either an increase or decrease by 20 mmHg or 20 bpm, respectively, while for SpO₂, we will consider values below 90% during the application of the maneuvers (26).

Sample size

We carried out our sample calculation on the statistical software G* Power 3.1^®. Considering the results of an intervention study by Olson et al (2009), addressing the influence of vibration maneuver on patients with intracranial hypertension risk initially presenting an average of 15.90 ± 5.7 vs 14.20 ± 8.5 cmH2O, the authors calculated that a sample of 24 patients per group would provide a power of 80% (Error Type I-α = 0.05 error Type II- β = 0.10).

Statistical Methods

The collected data will be organized on a spreadsheet and summarized using techniques of descriptive statistical analysis. The qualitative variables will be summarized by building frequency tables and the quantitative variables by calculating the descriptive measures (average, mean, standard deviation, and percentiles 25–75).

We used the statistical software Statistical Package for the Social Sciences (SPSS) (IBM – version 22) to analyze the collected data. The normality assumption of the variables will be verified through a Shapiro-Wilk Test. Our research hypotheses will be tested using non-parametric methods. Wilcoxon Test with Kruskal-Wallis post-test will also be applied (intergroups). The level of significance established was p ≤ 0.05.

Dissemination plans

We aim to publish results from the study in international peer-reviewed journals brain injury rehabilitation. The full protocol, participant-level dataset, and statistical code are granted public access.

Ethical considerations

All data will only be accessed by the study researchers and kept strictly confidential. Patient data will be protected by locked cabinets, and use of passwords limited access storage of electronic data. Data will be collected on paper forms, and scanned in sequence. As a way to avoid errors, they will be double-checked when they are scanned.

Stroke is among the acute cerebral lesions that present the highest morbidity and mortality in the world and has been increasingly growing (2). These patients are admitted to Intensive Care Units due to the severity of the lesion and need for MV, which is related to the lesion region and consequent deficits in airway protection, level of awareness, and respiratory control (2).

Patients under MV have a high risk of bronchial secretions retention. Furthermore, tracheal intubation is related to lower effectiveness and cough reflex, interruption of mucociliary system, rheologic modification of the mucus, in addition to immobility imposed on the patient, general weakness, and fluid restriction, which can contribute to enhancing the viscosity of the mucus and need for bronchial hygiene maneuver (1, 27–30).

When applied on the chest, these maneuvers increase the ITP, with a decrease in venous return, heart debt and MAP (31). Therefore, techniques applied in physiotherapy can cause transitory hemodynamic alterations, including in the ICP (1, 32). The difference between MAP and ICP characterizes cerebral perfusion pressure, and the pressure gradient enables blood circulation in the intracranial constituents (1). Thus, alterations in any of these components without increasing or reducing the others can worsen the cerebral lesion by hypoxic-ischemic involvement (33). In this way, the relationship between the cardiorespiratory and cerebral systems is evident (1).

Recent studies demonstrate the importance of neurological monitoring in the outcome of neurocritical patients (34). The analysis of the average of the ICP pulses, by the morphology of the waveform, makes it possible to obtain the data of the P2/P1 ratio and the TTP, which characterizes the ICC. ICC seems to better reflect intracranial homeostasis than the absolute value of ICP itself (35).

This is the first randomized clinical protocol to propose and verify the effectiveness of an MHM and its influence on the ICP of critical neurological patients through a non-invasive assessment of ICP, supported by an extensive literature review.

With this study, we expect to demonstrate the safety of performing hyperinflation maneuvers under a mechanical ventilator in critical neurological patients, proving to be a respiratory physiotherapy resource that can be used in clinical practice and provide benefits to lung mechanics without jeopardizing the neurological function.

B4C: Brain4care

CG: Control Group

CO: Cardiac output

CO2: Carbon gas

DD: Dorsal decubitus

DynC: Dynamic compliance

EG: Experimental Group

ETCO2: End Tidal CO2

FIO2: Inspired oxygen fraction

HR: Heart rate

IC: Informed Consent

ICC: Intracranial Compliance

ICP: Intracranial pressure

ICU: Intensive Care Units

ITP: Intrathoracic pressure

MAP: Mean arterial pressure

MHM: Mechanical Hyperinflation Maneuver

MV: Mechanical ventilation

PEEP: Positive expiratory-end pressure;

PEF: Peak of expiratory flow

PIF: Peak of inspiratory flow

Ppeak: Peak pressure

Pplateau: Plateau pressure

RASS: Richmond Agitation-Sedation Scale

Re: Resistance

RR: Respiratory rate

SpO2: Peripheral oxygen saturation

StaC: Static compliance

Ti: Inspiratory time

TTP: Time to peak

V: Flow

Vt: Tidel volume

TRIAL STATUS

At the time of manuscript submission the study is in the recruitment phase. Recruiting started in March 26, 2019 and will continue until the target sample size is reached, which is expected to occur during November, 2022.

Ethics approval and consent to participate

This study has been approved by Ethics Committee for Research on Human Beings of Clinical Hospital of the Federal University of Paraná (Ethics approval number: 3.142.091). Written, informed consent to participate will be obtained from all participants.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Consent for publication

The consent form is available upon request.

Competing interests

The authors declare that they have no competing interests.

Funding

This research received no external funding.

Authors' Contributions

DAS and MWB was involved in the conception, recruiting patients, drafted the manuscript and design of the research. AMDZ, SYMT and HCJ participated in manuscript review. SV participated in conception, drafted the manuscript, design of the research and coordinated trials. All authors reviewed the content and approved the final version of the manuscript.

Acknowledgements

The authors thank a Brain4care for all providing technical support.

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Mechanical Hyperinflation Maneuver and intracranial pressure of critical neurological patients: protocol for a randomized clinical trial.

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Abstract

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Introduction

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