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Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine

Study acronym: BAROLO
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later May 2028 → May 2029
Enrollment reduced 12% 80 → 70 participants
See other at-risk trials from Sahlgrenska University Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from May 2028 to May 2029 Show 8 more changesShow less
    • Enrollment reduced: 80 → 70 participants
    • Study completion pushed from Oct 2028 to Oct 2029
    • Start date: Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 15 to 16
    • Study description expanded, about 88 words
    • Study site revised
    • Study title shortened, about 1 word
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Right ventricular failure (RVF) is a common complication to cardiac surgery, which is associated to mortality, kidney failure, stroke, prolonged mechanical ventilation and ICU stay. The right ventricle is particularly vulnerable to an increased afterload. By increasing pulmonary vascular resistance (PVR), atelectasis might mitigate a negative effect on the right ventricle. Recruitment maneuvers have been shown to resolve atelectasis and improve hemodynamics by increasing cardiac output and lowering PVR. However these maneuvers transiently raise airway pressures, which in turn increases right ventricular afterload, a situation often poorly tolerated by patients with RVF. Prone position is used in patients with respiratory failure and has been shown to decrease mortality in patients with ARDS. Prone position decreases atelectasis and moves ventilation dorsally. In ARDS it also seems to mediate beneficial hemodynamic effects such as an increase in cardiac output and a decrease in PVR. The investigators hypothesis is that prone position early after cardiac surgery will increase cardiac output by recruitment of atelectasis and thereby decrease PVR.
Trial Details
NCT Number NCT07632027
Lead Sponsor Sahlgrenska University Hospital
Conditions
(from sponsor)
Right Ventricular Function, Prone Position, Atelectasis, Atelectases, Postoperative Pulmonary, Cardiac Output, Vasoconstriction, Heart Failure, Recruitment Maneuver +5 more
Related terms Heart Failure, Pulmonary Atelectasis
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov