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Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

ConditionsAcute Respiratory Distress Syndrome (ARDS)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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Spontaneous Ventilation Strategy

    Procedure/Surgery

    Invasive mechanical ventilation strategy allowing spontaneous breathing while receiving ventilatory support from a standard ICU mechanical ventilator.

  • Controlled Ventilation Strategy

    Procedure/Surgery

    Invasive mechanical ventilation strategy in which spontaneous respiratory effort is suppressed and breaths are fully delivered by a standard ICU mechanical ventilator.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Spontaneous ventilationExperimental treatment 1 intervention
Group B: Controlled ventilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Proportion of eligible patients who are enrolled in the trial (primary feasibility outcome).

Time frame
1 year from trial initiation

Secondary outcomes

1

Consent Rate

Proportion of eligible patients who provide informed consent to participate in the trial.

Time frame
1 year from trial initiation
2

Randomisation Rate

Proportion of consented participants who are randomised.

Time frame
1 year from trial initiation
3

Protocol Adherence

Proportion of study procedures completed according to protocol requirements.

Time frame
1 year from trial initiation
4

Major Protocol Violations

Proportion of enrolled participants with at least one major protocol deviation.

Time frame
1 year from trial initiation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Oslo University Hospital

Lead sponsor

Rigshospitalet, Denmark

Collaborator

Aalborg University Hospital

Collaborator

Source ClinicalTrials.gov

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