Comparison of two weaning strategies using either non-synchronized biphasic ventilation (mode 'Biphasic Positive Airway Pressure Ventilation' (BIPAP)) or assisted inspiratory ventilation (AI): randomized feasibility study.

Switzerland (ICTRP)

ICTRP Trial ID
NCT06912906 (ICTRP)

Official title (approved by ethics committee)
BIWEAN - Comparison of two strategies to allow mechanical ventilation separation using either Biphasic Positive Airway Pressure Ventilation without any synchronization (BIPAP) or Pressure Support Ventilation (PSV): a randomized feasibility trial (BASEC)

Academic 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 (ICTRP)

Public title
Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning (ICTRP)

Disease under investigation
Mechanical Ventilation Weaning (ICTRP)

Intervention under investigation
Procedure: BIPAPasynchro: byphaisc positive pressure modality without any synchronisation (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
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-Barr, 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) (ICTRP)

not available

Primary and secondary end points
Percentage of time spent in the mode of assisted ventilation assigned by the randomization (ICTRP)

The proportions of participants who are switched to the non-assigned mode (cross-over from one study group to the other);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;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;Ventilator-free-days at day 28 from intubation;Ventilator-free-days at day 28 from randomization;Duration of invasive mechanical ventilation between randomization and successful weaning;Duration of invasive mechanical ventilation between randomization and successful weaning;Number of tracheostomized patients during the weaning process;Number of patients matching the criteria for difficult or prolonged weaning;Length of ICU stay;ICU-free days at day 90 from randomization;Length of Hospital stay;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;Hospital mortality (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Lise Piquilloud ImbodenLise Piquilloud Imboden, MD Phd, lise.piquilloud@chuv.chlise.piquilloud@chuv.ch, +417955668270041795566827 (ICTRP)

Secondary trial IDs
2024-00432 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06912906 (ICTRP)