Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning (BIWEAN)

April 10, 2025 updated by: Piquilloud Imboden Lise, University of Lausanne Hospitals

Comparison of Two Strategies to Allow Mechanical Ventilation Separation Using Biphasic Airway Pressure Ventilation Without Any Synchronization (BIPAP) or Pressure Support Ventilation (PSV): a Randomized Feasibility Trial

We hypothesize that the ventilatory mode Bilevel Positive Airway Pressure without any synchronization (BIPAPasynchro) may facilitate the weaning process of patients intubated with acute hypoxiemic respiratory failure (AHRF) by obviating the problem of patient-ventilator asynchrony. In order to prove this hypothesis a large randomized controlled study should be perfromed comparing BIPAPasynchro versus pressure support ventilation (PSV), the most widely used ventilatory mode during the weaning process. In order to do so, a feasibility trial to demonstrate the ICU personnel can effectively use a non-standard ventilatory mode should be first performed. The objective of our study is, thus, to demonstrate the feasibility of using BIPAasynchro in the Lausanne Adult ICU.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bilevel Positive Airway Pressure without any synchronization (BIPAPasynchro) ventilation is a ventilatory modality that guarantees a minimal mandatory minute ventilation, even in deeply sedated patients, and allows free spontaneous breathing as soon as possible, without requiring synchronization between the patient and the ventilator. The hypothesis is that, as it obviates the problem of patient-ventilator asynchrony, it could reduce, compared to pressure support ventilation (PSV), the need of sedation, decrease diaphragmatic atrophy and accelerate the liberation from mechanical ventilation (weaning phase) without exposing the patients to further risks. Data seems to suggest a potential benefit of BIPAPasynchro over PSV, but no large randomized controlled trials have been performed to compare the two techniques; however, this cannot be done after first demonstrating that it is feasible to use BIPAPasynchro in the weaning process from mechanical ventilation in the intensive care unit.

The present project aims at assessing the feasibility of using a standardized BIPAP weaning strategy. It is thus a feasibility trial that assesses the adherence to the use of the mode. It is a randomized trial with two parallel groups in which we will compare the percentage of time effectively spent in the assigned mode, either BIPAP asynchro (intervention group) or PSV (control group), since the first switch from assist-control ventilation to assisted ventilation.

The study primary endpoint is the percentage of patients who spent at least 65% of the time (a priori-chosen cut-off) in the assigned mode (either BIPAPasynchro or PSV mode) since the first switch to assisted ventilation until successful liberation from mechanical ventilation. Liberation from mechanical ventilation (successful weaning) is defined as follows: 1) for intubated patients, we consider the patient weaned from ventilation when extubated without reintubation within 72 hours. 2) For tracheostomized patients, we consider the patient weaned from ventilation as soon as ventilated less than 12h over 24h during three consecutive days.

The secondary endpoints are divided in other-feasibility endpoints, safety endpoints and exploratory endpoints.

The study secondary feasibility endpoints are:

  1. the proportions of participants who are switched to the non-assigned mode (cross-over from one study group to the other). Concretely, this refers to the situations where the patients in the PSV group are ventilated in BIPAPasynchro and the patients in the BIPAPasynchro group are ventilated in PSV.
  2. The percentage of time spent in the non-assigned ventilatory mode since patient inclusion;
  3. reasons for cross-over;
  4. physicians refusal rate of patient enrolment;
  5. reasons of physicians refusal if applicable;

  6. recruitment rates.

    Secondary safety endpoints

    The study secondary safety endpoints are:

  7. pneumothoraxes rate;
  8. unplanned extubation rate;
  9. rate of severe respiratory acidosis (pH < 7.20);
  10. rate of severe respiratory alkalosis (pH > 7.55);

  11. ventilation acquired pneumonia (VAP) rate (13).

    Secondary exploratory endpoints

    The study secondary exploratory endpoints are:

  12. ventilator-free-days at day 28 from intubation (VFDs-28);
  13. ventilator-free-days at day 28 from randomization;
  14. duration of invasive mechanical ventilation between randomization and successful weaning, as defined in § 2.2.1;
  15. duration of invasive mechanical ventilation between randomization and successful weaning, defined as no reintubation (or reventilation) during 7 days after extubation
  16. number of tracheostomized patients during the weaning process;
  17. number of patients matching the criteria for difficult or prolonged weaning (14).
  18. length of ICU stay (censored at day 90 after randomization);
  19. ICU-free days at day 90 from randomization;
  20. length of Hospital stay (censored at day 90 from randomization);
  21. hospital-free days at day 90 from randomization;
  22. proportion of days with RASS less or equal -2 (for almost 50% of daily assessments) during invasive mechanical ventilation;
  23. proportion of days with sedation during invasive mechanical ventilation;
  24. proportion of days with neuromuscular blocking agents administration for ventilation facilitation during invasive mechanical ventilation;
  25. ICU mortality (censored at day 90 from randomization);
  26. hospital mortality (censored at day 90 from randomization).

This is a prospective, open-label, parallel-group, randomized feasibility trial taking place in the Adult ICU of the University Hospital of Lausanne, Switzerland. Due to the nature of the research, this is an open-label study. Patients will be randomized with a 1:1 ratio for receiving either BIPAPasynchro or PSV as soon as switching to assisted ventilation is considered as possible by the attending physician.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Lausanne, Switzerland
        • Lausanne University Hospital (CHUV)
    • VD
      • Lausanne, VD, Switzerland, 1011
        • University Hospital of Lausanne
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Intubated ICU patient with acute respiratory failure;
  • PaO2-FiO2 ratio of less than 300 mmHg (40 kPa) at least one hour after intubation;
  • control or assist-control ventilation;
  • expected duration of mechanical ventilation of more than 24 hours;
  • clinician in charge considers that the patient can be switched to assisted ventilation (weaning phase start);
  • informed consent obtained by the patient himself / legal representative or authorization received from independent physician

Exclusion Criteria:

  • less than 18 years old;
  • pregnant women (because of very different respiratory mechanics);
  • severe obesity (BMI > 40 kg/m2);
  • known obstructive pulmonary disease;
  • expected death within one week or very poor prognosis with end-of-life care decision expected/treatment withdrawal;
  • neurological disorders heavily influencing breathing pattern, like suspected or proven hypoxic brain injury, spinal injury above C8, severe traumatic brain injury, polyneuropathies (ex. Guillain-Barré, myasthenia gravis);
  • home non-invasive ventilation prior to ICU admission, except CPAP for obstructive sleeping apnoea syndrome;
  • tracheostomised at ICU admission;
  • suspected or proven broncho-pleural fistulas;
  • extracorporeal membrane oxygenation (ECMO) treatment;
  • ICU admission for major burns;
  • enrolment in other trial with competitive outcomes or treatment strategies;
  • Known opposition to research participation if patient is not able to consent (eg patient with refused GC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care: Pressure support ventilation (PSV)
Patient will be weaned from mechanical ventilation using the pressure support ventilation (PSV) modality accoring to the local standard of care.
Experimental: Biphasic positive airway pressure without any synchronisation (BIPAPasynchro)
Patients will be managed with byphaisc positive pressure modality without any synchronisation (BIPAPasynchro) as soon as they are considered to be ready to initiate the weaning phase from mechanical ventilation. Lausanne adult intesive care physicians will be provided a protocol to help guide them with the setting of BIPAPasynchro, as this is different from standard clinical pratice.
Procedure: BIPAPasynchro: byphaisc positive pressure modality without any synchronisation
Patients will be switched to byphaisc positive pressure modality without any synchronisation (BIPAPasynchro) as soon as they are considered to be ready to initiate the weaning phase from mechanical ventilation. Lausanne adult intesive care physicians will be provided a protocol to help guide them with the setting of BIPAPasynchro, as this is different from standard clinical pratice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time spent in the mode of assisted ventilation assigned by the randomization
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportions of participants who are switched to the non-assigned mode (cross-over from one study group to the other)
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
This refers to the situations where the patients in the PSV group are ventilated in BIPAPasynchro and the patients in the BIPAPasynchro group are ventilated in PSV.
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
The percentage of time spent in the non-assigned ventilatory mode since patient inclusion
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Reasons for cross-over
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Reason why the patient is ventilated with another ventilatory mode compared to the one to which he was assigned at randomisation
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Physicians refusal rate of patient enrolment
Time Frame: At time of potential enrollement
At time of potential enrollement
Reasons of physicians refusal if applicable
Time Frame: At time of potential enrollement
At time of potential enrollement
Recruitment rates
Time Frame: At time of enrollment
At time of enrollment
Pneumothoraxes rate
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Unplanned extubation rate
Time Frame: From enrollement until liberation from mechanical ventilaton or death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilaton or death, whichever comes first, assessed up to 90 days
Rate of severe respiratory acidosis (pH < 7.20)
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Rate of severe respiratory alkalosis (pH > 7.55)
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Ventilation acquired pneumonia (VAP) rate
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Ventilator-free-days at day 28 from intubation
Time Frame: from intubation to 28 days after intubation
from intubation to 28 days after intubation
Ventilator-free-days at day 28 from randomization
Time Frame: from randomization until 28 days after randomisation
from randomization until 28 days after randomisation
Duration of invasive mechanical ventilation between randomization and successful weaning
Time Frame: from randomization until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
Liberation from mechanical ventilation (successful weaning) is defined as follows: 1) for intubated patients, we consider the patient weaned from ventilation when extubated without reintubation within 72 hours. 2) For tracheostomized patients, we consider the patient weaned from ventilation as soon as ventilated less than 12h over 24h during three consecutive days.
from randomization until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
Duration of invasive mechanical ventilation between randomization and successful weaning
Time Frame: from randomization until successful liberation from mechanical ventilation or death, whichever comes first, assessed up to up to 90 days
Successful weaning defined as no reintubation (or reventilation) during 7 days after extubation
from randomization until successful liberation from mechanical ventilation or death, whichever comes first, assessed up to up to 90 days
Number of tracheostomized patients during the weaning process
Time Frame: From enrollement until liberation from mechanical ventilaton or death, whichever comes first, assessed up to 90 days
From enrollement until liberation from mechanical ventilaton or death, whichever comes first, assessed up to 90 days
Number of patients matching the criteria for difficult or prolonged weaning
Time Frame: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Difficult weaning defined as more than 1 day and less than 1 week and prolonged weaning defined as weaning duration of 1 week or more
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Length of ICU stay
Time Frame: from randomization until 90 days after randomization
from randomization until 90 days after randomization
ICU-free days at day 90 from randomization
Time Frame: from randomization until 90 days after randomization
from randomization until 90 days after randomization
Length of Hospital stay
Time Frame: from randomization until 90 days after randomization
from randomization until 90 days after randomization
Hospital-free days at day 90 from randomization
Time Frame: from randomization until 90 days after randomization
from randomization until 90 days after randomization
Proportion of days with RASS less or equal -2 (for almost 50% of daily assessments) during invasive mechanical ventilation;
Time Frame: from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
Proportion of days with sedation during invasive mechanical ventilation
Time Frame: from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
Proportion of days with neuromuscular blocking agents administration for ventilation facilitation during invasive mechanical ventilation
Time Frame: from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
ICU mortality
Time Frame: from randomization until 90 days after randomization
from randomization until 90 days after randomization
Hospital mortality
Time Frame: from randomization until 90 days after randomization
from randomization until 90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-00432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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