Mechanical Ventilation WeaningBIWEANNCT06912906
Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning
A study testing BIPAPasynchro: byphaisc positive pressure modality without any synchronisation in people with Mechanical Ventilation Weaning, run by University of Lausanne Hospitals at 2 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Weaning
- What is being tested?
- BIPAPasynchro: byphaisc positive pressure modality without any synchronisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
Show all 13Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
University Hospital of Lausanne
Lausanne, Canton of Vaud, 1011
Lise Piquilloud Imboden, MD Phd, 0041795566827, lise.piquilloud@chuv.ch
Giulia Lais, MD, 00417955666671, Giulia.Lais@chuv.ch
Lausanne University Hospital (CHUV)
Lausanne
About this study
Official title: 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.
Read the 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:
- 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.
- The percentage of time spent in the non-assigned ventilatory mode since patient inclusion;
- reasons for cross-over;
- physicians refusal rate of patient enrolment;
- reasons of physicians refusal if applicable;
- recruitment rates. Secondary safety endpoints The study secondary safety endpoints are:
- pneumothoraxes rate;
- unplanned extubation rate;
- rate of severe respiratory acidosis (pH < 7.20);
- rate of severe respiratory alkalosis (pH > 7.55);
- ventilation acquired pneumonia (VAP) rate (13). Secondary exploratory endpoints The study secondary exploratory endpoints are:
- ventilator-free-days at day 28 from intubation (VFDs-28);
- ventilator-free-days at day 28 from randomization;
- duration of invasive mechanical ventilation between randomization and successful weaning, as defined in § 2.2.1;
- duration of invasive mechanical ventilation between randomization and successful weaning, defined as no reintubation (or reventilation) during 7 days after extubation
- number of tracheostomized patients during the weaning process;
- number of patients matching the criteria for difficult or prolonged weaning (14).
- length of ICU stay (censored at day 90 after randomization);
- ICU-free days at day 90 from randomization;
- length of Hospital stay (censored at day 90 from randomization);
- hospital-free days at day 90 from randomization;
- proportion of days with RASS less or equal -2 (for almost 50% of daily assessments) during invasive mechanical ventilation;
- proportion of days with sedation during invasive mechanical ventilation;
- proportion of days with neuromuscular blocking agents administration for ventilation facilitation during invasive mechanical ventilation;
- ICU mortality (censored at day 90 from randomization);
- 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.
- Conditions
- Mechanical Ventilation Weaning
- Being tested
- BIPAPasynchro: byphaisc positive pressure modality without any synchronisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAPasynchro: byphaisc positive pressure modality without any synchronisationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care: Pressure support ventilation (PSV) | No intervention | Patient will be weaned from mechanical ventilation using the pressure support ventilation (PSV) modality accoring to the local standard of care. |
| Biphasic positive airway pressure without any synchronisation (BIPAPasynchro) | Experimental | 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. Receives: Procedure: BIPAPasynchro: byphaisc positive pressure modality without any synchronisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in the mode of assisted ventilation assigned by the randomization
Measured: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Secondary outcomes (26)
The proportions of participants who are switched to the non-assigned mode (cross-over from one study group to the other)
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.
Measured: 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
Measured: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Reasons for cross-over
Reason why the patient is ventilated with another ventilatory mode compared to the one to which he was assigned at randomisation
Measured: 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
Measured: At time of potential enrollement
Reasons of physicians refusal if applicable
Measured: At time of potential enrollement
Recruitment rates
Measured: At time of enrollment
Pneumothoraxes rate
Measured: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Unplanned extubation rate
Measured: 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)
Measured: 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)
Measured: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Ventilation acquired pneumonia (VAP) rate
Measured: 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
Measured: from intubation to 28 days after intubation
Ventilator-free-days at day 28 from randomization
Measured: from randomization until 28 days after randomisation
Duration of invasive mechanical ventilation between randomization and successful weaning
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.
Measured: 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
Successful weaning defined as no reintubation (or reventilation) during 7 days after extubation
Measured: 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
Measured: 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
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
Measured: From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
Length of ICU stay
Measured: from randomization until 90 days after randomization
ICU-free days at day 90 from randomization
Measured: from randomization until 90 days after randomization
Length of Hospital stay
Measured: from randomization until 90 days after randomization
Hospital-free days at day 90 from randomization
Measured: 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;
Measured: 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
Measured: 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
Measured: from first intubation until liberation from mechanical ventilation or death, whichever comes first, assessed up to 90 days
ICU mortality
Measured: from randomization until 90 days after randomization
Hospital mortality
Measured: from randomization until 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piquilloud Imboden Lise, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912906
- Sponsor's protocol ID
- 2024-00432
- Acronym
- BIWEAN
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baum M, Benzer H, Putensen C, Koller W, Putz G. [Biphasic positive airway pressure (BIPAP)--a new form of augmented ventilation]. Anaesthesist. 1989 Sep;38(9):452-8. German.
PubMed 2686487Richard JM, Beloncle FM, Beduneau G, Mortaza S, Ehrmann S, Diehl JL, Prat G, Jaber S, Rahmani H, Reignier J, Boulain T, Yonis H, Richecoeur J, Thille AW, Declercq PL, Antok E, Carteaux G, Vielle B, Brochard L, Mercat A; REVA network. Pressure control plus spontaneous ventilation versus volume assist-control ventilation in acute respiratory distress syndrome. A randomised clinical trial. Intensive Care Med. 2024 Oct;50(10):1647-1656. doi: 10.1007/s00134-024-07612-3. Epub 2024 Sep 17.
PubMed 39287651Gama de Abreu M, Cuevas M, Spieth PM, Carvalho AR, Hietschold V, Stroszczynski C, Wiedemann B, Koch T, Pelosi P, Koch E. Regional lung aeration and ventilation during pressure support and biphasic positive airway pressure ventilation in experimental lung injury. Crit Care. 2010;14(2):R34. doi: 10.1186/cc8912. Epub 2010 Mar 16.
PubMed 20233399Richard JC, Lyazidi A, Akoumianaki E, Mortaza S, Cordioli RL, Lefebvre JC, Rey N, Piquilloud L, Sferrazza Papa GF, Mercat A, Brochard L. Potentially harmful effects of inspiratory synchronization during pressure preset ventilation. Intensive Care Med. 2013 Nov;39(11):2003-10. doi: 10.1007/s00134-013-3032-7. Epub 2013 Aug 9.
PubMed 23928898Katzenschlager S, Simon CM, Rehn P, Grilli M, Fiedler MO, Muller M, Weigand MA, Neetz B. Time-controlled adaptive ventilation in patients with ARDS-lack of protocol adherence: a systematic review. Crit Care. 2023 Feb 10;27(1):57. doi: 10.1186/s13054-023-04340-w. No abstract available.
PubMed 36765424Rathgeber J, Schorn B, Falk V, Kazmaier S, Spiegel T, Burchardi H. The influence of controlled mandatory ventilation (CMV), intermittent mandatory ventilation (IMV) and biphasic intermittent positive airway pressure (BIPAP) on duration of intubation and consumption of analgesics and sedatives. A prospective analysis in 596 patients following adult cardiac surgery. Eur J Anaesthesiol. 1997 Nov;14(6):576-82. doi: 10.1046/j.1365-2346.1994.00178.x.
PubMed 9466092Elrazek EA. Randomized prospective crossover study of biphasic intermittent positive airway pressure ventilation (BIPAP) versus pressure support ventilation (PSV) in surgical intensive care patients. Middle East J Anaesthesiol. 2004 Oct;17(6):1009-21.
PubMed 15651509Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
PubMed 18633595Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272Jubran A, Grant BJ, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Effect of pressure support vs unassisted breathing through a tracheostomy collar on weaning duration in patients requiring prolonged mechanical ventilation: a randomized trial. JAMA. 2013 Feb 20;309(7):671-7. doi: 10.1001/jama.2013.159.
PubMed 23340588Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PubMed 27626706Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
PubMed 27418577Hadfield DJ, Rose L, Reid F, Cornelius V, Hart N, Finney C, Penhaligon B, Molai J, Harris C, Saha S, Noble H, Clarey E, Thompson L, Smith J, Johnson L, Hopkins PA, Rafferty GF. Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation. Crit Care. 2020 May 14;24(1):220. doi: 10.1186/s13054-020-02923-5.
PubMed 32408883Roshdy A, Elsayed AS, Saleh AS. Airway Pressure Release Ventilation for Acute Respiratory Failure Due to Coronavirus Disease 2019: A Systematic Review and Meta-Analysis. J Intensive Care Med. 2023 Feb;38(2):160-168. doi: 10.1177/08850666221109779. Epub 2022 Jun 22.
PubMed 35733377
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06912906
- Acronym / sponsor ID
- BIWEAN / 2024-00432
- Conditions
- Mechanical Ventilation Weaning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- The percentage of time spent in the non-assigned ventilatory mode since patient inclusion;
- reasons for cross-over;
- physicians refusal rate of patient enrolment;
- reasons of physicians refusal if applicable;
- recruitment rates. Secondary safety endpoints The study secondary safety endpoints are:
- pneumothoraxes rate;
- unplanned extubation rate;
- rate of severe respiratory acidosis (pH < 7.20);
- rate of severe respiratory alkalosis (pH > 7.55);
- ventilation acquired pneumonia (VAP) rate (13). Secondary exploratory endpoints The study secondary exploratory endpoints are:
- ventilator-free-days at day 28 from intubation (VFDs-28);
- ventilator-free-days at day 28 from randomization;
- duration of invasive mechanical ventilation between randomization and successful weaning, as defined in § 2.2.1;
- duration of invasive mechanical ventilation between randomization and successful weaning, defined as no reintubation (or reventilation) during 7 days after extubation
- number of tracheostomized patients during the weaning process;
- number of patients matching the criteria for difficult or prolonged weaning (14).
- length of ICU stay (censored at day 90 after randomization);
- ICU-free days at day 90 from randomization;
- length of Hospital stay (censored at day 90 from randomization);
- hospital-free days at day 90 from randomization;
- proportion of days with RASS less or equal -2 (for almost 50% of daily assessments) during invasive mechanical ventilation;
- proportion of days with sedation during invasive mechanical ventilation;
- proportion of days with neuromuscular blocking agents administration for ventilation facilitation during invasive mechanical ventilation;
- ICU mortality (censored at day 90 from randomization);
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care: Pressure support ventilation (PSV) | No intervention | –Patient will be weaned from mechanical ventilation using the pressure support ventilation (PSV) modality accoring to the local standard of care. |
| Biphasic positive airway pressure without any synchronisation (BIPAPasynchro) | Experimental | Procedure: BIPAPasynchro: byphaisc positive pressure modality without any synchronisationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIPAPasynchro: byphaisc positive pressure modality without any synchronisationPatients 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. | Procedure or surgery | Biphasic positive airway pressure without any synchronisation (BIPAPasynchro) |
Primary outcome
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
26 secondary outcomes
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
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
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
Physicians refusal rate of patient enrolment
Time frame: At time of potential enrollement
Reasons of physicians refusal if applicable
Time frame: At time of potential enrollement
Recruitment rates
Time frame: 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
Unplanned extubation rate
Time frame: 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
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
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
Ventilator-free-days at day 28 from intubation
Time frame: from intubation to 28 days after intubation
Ventilator-free-days at day 28 from randomization
Time frame: 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
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
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
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
Length of ICU stay
Time frame: from randomization until 90 days after randomization
ICU-free days at day 90 from randomization
Time frame: from randomization until 90 days after randomization
Length of Hospital stay
Time frame: from randomization until 90 days after randomization
Hospital-free days at day 90 from randomization
Time frame: 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
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
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
ICU mortality
Time frame: from randomization until 90 days after randomization
Hospital mortality
Time frame: from randomization until 90 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 2686487Baum M, Benzer H, Putensen C, Koller W, Putz G. [Biphasic positive airway pressure (BIPAP)--a new form of augmented ventilation]. Anaesthesist. 1989 Sep;38(9):452-8. German.
- Background: PubMed 39287651Richard JM, Beloncle FM, Beduneau G, Mortaza S, Ehrmann S, Diehl JL, Prat G, Jaber S, Rahmani H, Reignier J, Boulain T, Yonis H, Richecoeur J, Thille AW, Declercq PL, Antok E, Carteaux G, Vielle B, Brochard L, Mercat A; REVA network. Pressure control plus spontaneous ventilation versus volume assist-control ventilation in acute respiratory distress syndrome. A randomised clinical trial. Intensive Care Med. 2024 Oct;50(10):1647-1656. doi: 10.1007/s00134-024-07612-3. Epub 2024 Sep 17.
- Background: PubMed 20233399Gama de Abreu M, Cuevas M, Spieth PM, Carvalho AR, Hietschold V, Stroszczynski C, Wiedemann B, Koch T, Pelosi P, Koch E. Regional lung aeration and ventilation during pressure support and biphasic positive airway pressure ventilation in experimental lung injury. Crit Care. 2010;14(2):R34. doi: 10.1186/cc8912. Epub 2010 Mar 16.
- Background: PubMed 23928898Richard JC, Lyazidi A, Akoumianaki E, Mortaza S, Cordioli RL, Lefebvre JC, Rey N, Piquilloud L, Sferrazza Papa GF, Mercat A, Brochard L. Potentially harmful effects of inspiratory synchronization during pressure preset ventilation. Intensive Care Med. 2013 Nov;39(11):2003-10. doi: 10.1007/s00134-013-3032-7. Epub 2013 Aug 9.
- Background: PubMed 36765424Katzenschlager S, Simon CM, Rehn P, Grilli M, Fiedler MO, Muller M, Weigand MA, Neetz B. Time-controlled adaptive ventilation in patients with ARDS-lack of protocol adherence: a systematic review. Crit Care. 2023 Feb 10;27(1):57. doi: 10.1186/s13054-023-04340-w. No abstract available.
- Background: PubMed 9466092Rathgeber J, Schorn B, Falk V, Kazmaier S, Spiegel T, Burchardi H. The influence of controlled mandatory ventilation (CMV), intermittent mandatory ventilation (IMV) and biphasic intermittent positive airway pressure (BIPAP) on duration of intubation and consumption of analgesics and sedatives. A prospective analysis in 596 patients following adult cardiac surgery. Eur J Anaesthesiol. 1997 Nov;14(6):576-82. doi: 10.1046/j.1365-2346.1994.00178.x.
- Background: PubMed 15651509Elrazek EA. Randomized prospective crossover study of biphasic intermittent positive airway pressure ventilation (BIPAP) versus pressure support ventilation (PSV) in surgical intensive care patients. Middle East J Anaesthesiol. 2004 Oct;17(6):1009-21.
- Background: PubMed 18633595Rose L, Hawkins M. Airway pressure release ventilation and biphasic positive airway pressure: a systematic review of definitional criteria. Intensive Care Med. 2008 Oct;34(10):1766-73. doi: 10.1007/s00134-008-1216-3. Epub 2008 Jul 17.
- Background: PubMed 20053272Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
- Background: PubMed 23340588Jubran A, Grant BJ, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Effect of pressure support vs unassisted breathing through a tracheostomy collar on weaning duration in patients requiring prolonged mechanical ventilation: a randomized trial. JAMA. 2013 Feb 20;309(7):671-7. doi: 10.1001/jama.2013.159.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Background: PubMed 27626706Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIPAPasynchro: byphaisc positive pressure modality without any synchronisation in people with Mechanical Ventilation Weaning, run by University of Lausanne Hospitals at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Piquilloud Imboden (+41795566827, lise.piquilloud@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06912906, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.