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Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Apr 29, 2026 to Jun 11, 2026
    • Primary completion date changed from estimate of Aug 15, 2026 to Oct 9, 2026
    • Study completion pushed from Sep 1, 2026 to Oct 15, 2026
    • Eligibility criteria expanded, about 15 words
  2. Re-verified, no change to tracked fieldsv3
  3. Study title shortened, about 5 wordsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Retrograde intrarenal surgery is commonly performed under general anesthesia for the treatment of renal stones. During the procedure, respiratory-related renal movement caused by positive-pressure ventilation may impair endoscopic image stability and reduce the efficiency of laser lithotripsy. This randomized controlled trial aims to compare the effects of normal ventilation and low tidal volume ventilation on intraoperative endoscopic image stability during RIRS using a video-based Motion Index. Eligible adult patients scheduled for elective RIRS under general anesthesia will be randomized in a 1:1 ratio to either normal tidal volume ventilation or low tidal volume ventilation. A standardized 60-second intraoperative video segment in which the stone and/or active laser lithotripsy is visible will be analyzed by blinded assessors. The primary outcome is the mean Motion Index value calculated from sequential video frames. Secondary outcomes include additional Motion Index parameters, laser activation time, anesthesia and surgical duration, intraoperative respiratory and hemodynamic safety parameters, vasopressor requirement, complications, and stone-free status at routine follow-up.
Trial Details
NCT Number NCT07643324
Lead Sponsor Hitit University
Conditions
(from sponsor)		 Renal Calculi
Related terms Kidney Calculi
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov