NCT07463885

Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

Spontaneous Versus Controlled Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure: A Feasibility Study and Pilot Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Acute hypoxemic respiratory failure is a condition that can progress to acute respiratory distress syndrome (ARDS), requiring invasive mechanical ventilation to support gas exchange and limit lung injury. ARDS guidelines recommend lung-protective ventilation strategies-specifically low tidal volumes and limited airway pressures-to reduce ventilator-induced lung injury. Observational studies, including the global LUNG SAFE project, have described the epidemiology and management of acute hypoxemic respiratory failure and ARDS. These studies report high mortality rates (global hospital mortality, 38.6%) associated with the severity of lung injury rather than strict fulfilment of ARDS criteria. They also reveal variability in the application of evidence-based ventilation strategies across institutions. This inconsistency highlights a barrier to progress: the lack of conclusive evidence guiding ventilation management in patients with acute hypoxemic respiratory failure. One unresolved issue is the role of spontaneous breathing during mechanical ventilation. Observational studies suggest that allowing spontaneous effort may reduce need for sedation and increase ventilator-free days. In contrast, preclinical models indicate that spontaneous breathing in severe lung injury may worsen outcomes through mechanisms such as patient-ventilator asynchrony and regional overdistension. This contrast underscores the need to balance potential benefits against physiological risks in the absence of adequate trial data. ARDS guidelines do not provide clear recommendations on this issue due to limited evidence. Only one large RCT has compared controlled ventilation to spontaneous breathing modes, finding no difference in short-term outcomes and not assessing long-term endpoints such as cognitive impairment or quality of life.As a result, clinicians must choose between guideline-based controlled ventilation and approaches that incorporate spontaneous breathing, within the context of evolving sedation practices and recovery goals. Given the variability of acute hypoxemic respiratory failure and the current evidence gap, genuine uncertainty ('clinical equipoise') exists regarding the optimal ventilation strategy. This supports the need for well-designed RCTs to determine whether spontaneous ventilation offers clinical benefit or harm. A recent survey of Nordic clinicians showed support for such a trial in patients with moderately severe acute hypoxemic respiratory failure, underscoring the relevance of this research. The SVALBARD study is a feasibility and pilot trial comparing spontaneous and controlled mechanical ventilation in patients with acute hypoxemic respiratory failure. The study will evaluate whether it is possible to recruit patients, apply the assigned ventilation strategies, and collect the required data in a reliable way. In addition, the study will collect descriptive clinical data to better understand patient characteristics and outcomes. The results will be used to improve the design and planning of a future randomized controlled trial. The trial will accrue 80 patients from eight different intensive care units, four in Norway and four in Denmark.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)
• Acute Hypoxemic Respiratory Failure

Interventions

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

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2028-03-30
• First posted: 2026-03-11
• Last updated: 2026-03-13