Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

Study acronym: SVALBARD
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 7 of 20 entries
    • Collaborators revised (2)
    • Publications: details revised at 5 of 5 entries
  2. Minor Interventions: Controlled ventilation (Other), Spontaneous ventilation (Other) to Controlled Ventilation Strategy (Procedure), Spontaneous Ventilation Strategy (Procedure)v2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07463885
Lead Sponsor Oslo University Hospital
Collaborators: Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital
Conditions
(from sponsor)
Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
Related terms Respiratory Distress Syndrome, Respiratory Insufficiency
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov