Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery (NCT07643324) | Clinical Trial Compass
RecruitingNot Applicable
Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery
Turkey (Türkiye)60 participantsStarted 2026-04-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged 18 years or older
* Patients scheduled for elective retrograde intrarenal surgery under general anesthesia
* ASA physical status I-III
* Patients who are able to read and understand the informed consent form
* Patients who provide written informed consent
Exclusion Criteria:
* Patients younger than 18 years
* Pregnancy
* Emergency surgery
* Severe chronic obstructive pulmonary disease, severe restrictive pulmonary disease, or preoperative hypercapnia
* Severe uncontrolled cardiovascular disease
* Active urinary tract infection, sepsis, or untreated infectious focus
* Cases in whom the standardized ventilation protocol is difficult to apply because of morbid obesity
* Patients scheduled for an additional major urological procedure in the same session
* Cases in which an intraoperative video recording of sufficient quality cannot be obtained
* Patients in whom the study protocol cannot be safely continued according to the investigator's clinical judgment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Motion Index During Retrograde Intrarenal Surgery
Timeframe: Intraoperative period, during a standardized 60-second video segment