Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning

NCT06912906 | Not Yet Recruiting

• 1 other identifier: 2024-00432
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Mechanical Ventilation Weaning

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in the mode of assisted ventilation assigned by the randomization

  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)

  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

  From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days

• Reasons for cross-over

  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

  At time of potential enrollement

• Reasons of physicians refusal if applicable

  At time of potential enrollement

Study Arms (2)

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.

Procedure: BIPAPasynchro: byphaisc positive pressure modality without any synchronisation

Interventions

BIPAPasynchro: byphaisc positive pressure modality without any synchronisation PROCEDURE

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.

Biphasic positive airway pressure without any synchronisation (BIPAPasynchro)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (2)

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Lausanne University Hospital (CHUV)

Lausanne, Switzerland

Location

Related Publications (24)

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Central Study Contacts

Lise Piquilloud Imboden

CONTACT

+41795566827; lise.piquilloud@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)