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Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

Sponsor: Oslo University Hospital • ClinicalTrials.gov ID: NCT07463885

Registry updated: 2026-10-15

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Description

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.

Interventions

Spontaneous Ventilation Strategy (Procedure)
Invasive mechanical ventilation strategy allowing spontaneous breathing while receiving ventilatory support from a standard ICU mechanical ventilator.
Controlled Ventilation Strategy (Procedure)
Invasive mechanical ventilation strategy in which spontaneous respiratory effort is suppressed and breaths are fully delivered by a standard ICU mechanical ventilator.

Eligibility criteria

Inclusion Criteria: We will include patients who fulfil all the following criteria: * 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. * AND new pulmonary infiltrate (uni- or bilateral) on chest x-ray or CT-scan obtained no more than 24 hours before randomisation. Exclusion Criteria: * 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. * Chronic hypercapnic respiratory failure defined as PaCO2 \> 8 kPa (60 mm Hg) in the outpatient setting. * Listed for lung transplant. * Acute heart failure / acute myocardial infarction / cardiac arrest during or causing index ICU admission. * Use of home oxygen. * Chronic mechanical ventilation for any reason except for non-invasive mechanical ventilation (CPAP/BIPAP) used solely for sleep apnoea disorder. * Currently receiving ECMO therapy. * Burns \>70 % total body surface. * Acute brain injury or stroke (any, including subarachnoid haemorrhage, SAH). * Intracranial hypertension. * Patients with planned repeat surgical interventions during current stay in ICU.

Conditions

Acute Respiratory Distress Syndrome (ARDS) Acute Hypoxemic Respiratory Failure

Locations

Oslo University Hospital - Rikshospitalet — Oslo, Oslo, Norway

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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