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Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study

Study acronym: VIOLET
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Enrolling by Invitation → Completed Primary completion date changed from estimate of Oct 31, 2026 to Sep 16, 2026 · Study completion date changed from estimate of Mar 31, 2027 to Sep 23, 2026 · Start date: Apr 2, 2026 to Apr 8, 2026 · 3 more Show 6 more changesShow less
    • Primary completion date changed from estimate of Oct 31, 2026 to Sep 16, 2026
    • Study completion date changed from estimate of Mar 31, 2027 to Sep 23, 2026
    • Start date: Apr 2, 2026 to Apr 8, 2026
    • Secondary endpoints: details revised at 9 of 15 entries
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 5 words
  2. Secondary endpoints: 18 to 15v4 See this version in full on ClinicalTrials.gov ↗
  3. Eligibility criteria revised Secondary endpoints: 19 to 18v3 Show 1 more changeShow less
    • Secondary endpoints: 19 to 18

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Enrolling by Invitation Completion date: Feb 1, 2027 to Mar 31, 2027 · Start date changed from estimate of Feb 1, 2026 to Apr 2, 2026 · Interventions: Low Intensity Mechanical Ventilation (Other) to Low Intensity Mechanical Ventilation (Device)v2 Show 3 more changesShow less
    • Completion date: Feb 1, 2027 to Mar 31, 2027
    • Start date changed from estimate of Feb 1, 2026 to Apr 2, 2026
    • Interventions: Low Intensity Mechanical Ventilation (Other) to Low Intensity Mechanical Ventilation (Device)
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.
Trial Details
NCT Number NCT07277244
Lead Sponsor Beth Israel Deaconess Medical Center
Conditions Robotic Surgery, Post Operative Pulmonary Complications
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov