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RECRUITING
NCT07643324
NA

Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery - A Randomized Controlled Trial

Sponsor: Hitit University

View on ClinicalTrials.gov

Summary

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.

Official title: Comparison of Normal Ventilation and Low Tidal Volume Ventilation During Retrograde Intrarenal Surgery (RIRS) Using Video-Based Motion Index: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-29

Completion Date

2026-09-01

Last Updated

2026-06-11

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

low tidal volume ventilation

Participants allocated to the normal tidal volume ventilation group will receive volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia. Tidal volume will be set at 6-8 mL/kg predicted body weight with 5 cmH₂O PEEP. Respiratory rate will be titrated to maintain EtCO₂ between 35 and 45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%.

Locations (1)

Hitit university

Çorum, Turkey (Türkiye)