Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SVALBARD trial is a feasibility and pilot study comparing spontaneous ventilation to controlled ventilation in adults with acute hypoxemic respiratory failure at risk of ARDS. It aims to determine whether the study procedures, interventions, and data collection are workable in this population and to describe key clinical variables to plan a future randomized trial. The trial builds on current lung-protective ventilation concepts and examines potential physiological and clinical implications of preserving spontaneous breathing during ventilation. Results will inform design choices for a larger, definitive study and help clarify the balance of risks and benefits for different ventilation strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Oslo University Hospital - Rikshospitalet
  Oslo, Oslo, Norway Recruiting

Study contacts

• Study coordinator: Jon Henrik Laake, MD, PHD
• Email: jlaake@ous-hf.no
• Phone: 0047 97660919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.