Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure (NCT07463885) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
80 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.