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Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning

ConditionMechanical Ventilation Weaning
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Lausanne Hospitals

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

less than 18 years old;

pregnant women (because of very different respiratory mechanics);

severe obesity (BMI > 40 kg/m2);

known obstructive pulmonary disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BIPAPasynchro: byphaisc positive pressure modality without any synchronisation

    Procedure/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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Standard of care: Pressure support ventilation (PSV)No intervention 0 interventions
Group B: Biphasic positive airway pressure without any synchronisation (BIPAPasynchro)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.

Time frame
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
2

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
3

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

Time frame
From enrollement until liberation from mechanical ventilation or date of death, whichever comes first, assessed up to 90 days
4

Physicians refusal rate of patient enrolment

Time frame
At time of potential enrollement

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Lausanne Hospitals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: