Status:

NOT_YET_RECRUITING

Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning

Lead Sponsor:

University of Lausanne Hospitals

Conditions:

Mechanical Ventilation Weaning

Eligibility:

All Genders

18+ years

Phase:

NA

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 res...

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 patien...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 15 2027

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT06912906

Start Date

September 1 2025

End Date

April 15 2027

Last Update

April 15 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University Hospital of Lausanne

Lausanne, Canton of Vaud, Switzerland, 1011

2

Lausanne University Hospital (CHUV)

Lausanne, Switzerland