Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain.
The SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure.
The primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.
Eligibility criteria
Qualifiers
Acutely admitted to the ICU
AND age ≥ 18 years
AND invasive mechanical ventilation via endotracheal tube or tracheostomy for less than 24 hours
AND moderate acute hypoxemic respiratory failure, defined as a PaO₂-FiO₂ ratio between 13.3-26.6 kPa (100-200 mmHg) with PEEP ≥ 5 cm H2O, based on arterial blood gas analysis obtained within 2 hours before randomisation.
Disqualifiers
Previously randomised into the SVALBARD trial.
Informed consent following inclusion expected to be unobtainable
Patient under coercive measures
Withdrawal from active therapy or brain death deemed imminent.
Trial design
Treatments tested in this trial
- Spontaneous Ventilation Strategy
- Controlled Ventilation Strategy
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Oslo University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Aalborg University Hospital
Collaborator
Source ClinicalTrials.gov