Hitit university
Çorum, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ozgur Yagan, Professor
CONTACT
NCT Number: NCT07643324
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Çorum, Turkey (Türkiye)
Location status: Recruiting
Ozgur Yagan, Professor
CONTACT
Retrograde intrarenal surgery (RIRS) is a minimally invasive endourological procedure widely used for the treatment of renal stones. Because the procedure is performed within the narrow collecting system of the kidney, endoscopic image stability is important for accurate laser targeting, efficient lithotripsy, and procedural safety. During general anesthesia, positive-pressure ventilation may cause diaphragmatic and respiratory-related renal movement, resulting in micro-movements of the endoscopic image. These movements may interfere with continuous laser targeting and may reduce procedural efficiency.
This study is designed as a single-center, prospective, randomized, parallel-group, assessor-blinded controlled trial. Adult patients scheduled for elective RIRS under general anesthesia will be enrolled after obtaining written informed consent. Participants will be randomized in a 1:1 ratio to one of two intraoperative ventilation strategies: normal tidal volume ventilation or low tidal volume ventilation. Randomization will be performed using a computer-generated randomization list, and allocation concealment will be ensured with sequentially numbered, opaque, sealed envelopes. The video assessors will be blinded to group allocation.
After induction of general anesthesia and endotracheal intubation, mechanical ventilation will be standardized according to the assigned group. In the normal ventilation group, tidal volume will be set at 6-8 mL/kg predicted body weight with 5 cmH₂O PEEP. In the low tidal volume ventilation group, tidal volume will be set at 4-6 mL/kg predicted body weight with 5 cmH₂O PEEP. In both groups, respiratory rate will be titrated to maintain EtCO₂ within the target range of 35-45 mmHg, and FiO₂ will be adjusted to maintain SpO₂ above 94%. Patient safety will take priority throughout the study, and ventilation settings may be modified if clinically required. Any protocol deviations will be recorded.
Intraoperative endoscopic videos obtained during routine RIRS will be used for the video-based analysis. After the procedure, video files will be anonymized and coded in a way that does not reveal group allocation. A standardized 60-second segment in which the stone is clearly visible and/or laser lithotripsy is active will be selected according to predefined criteria. The selected segments will be analyzed using a phase-correlation-based image registration method. Sequential video frames will be converted to grayscale, mild noise reduction will be applied, and horizontal and vertical image displacement between consecutive frames will be calculated. The Motion Index will be derived from these displacement components for each frame pair, generating a time series for each patient.
The primary outcome of the study is the mean Motion Index value calculated from the standardized intraoperative video segment. Secondary outcomes include additional Motion Index parameters, including median, 95th percentile, and maximum Motion Index values; laser activation time; anesthesia duration; surgical duration; intraoperative respiratory and hemodynamic parameters such as EtCO₂, SpO₂, mean arterial pressure, heart rate, airway pressures when available, and vasopressor requirement; perioperative complications; and stone-free status at routine postoperative follow-up, planned at approximately 4 weeks.
The study aims to determine whether low tidal volume ventilation improves endoscopic image stability during RIRS without compromising respiratory or hemodynamic safety. The findings may contribute to the standardization of anesthetic ventilation strategies during endourological stone surgery and may provide an objective, reproducible method for evaluating respiratory-related image motion during RIRS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%.
Other names: Normal Tidal Volume Ventilation
Time frame: Intraoperative period, during a standardized 60-second video segment
Mean Video-Based Motion Index will be calculated from a standardized 60-second intraoperative endoscopic video segment in which the stone is clearly visible and/or laser lithotripsy is active. The Video-Based Motion Index is a unitless image-motion metric derived from horizontal and vertical frame-to-frame displacement between consecutive video frames using a phase-correlation-based image registration method. The theoretical minimum value is 0, indicating no detected image displacement. There is no predefined fixed maximum value because the value depends on the magnitude of frame-to-frame displacement. Higher values indicate greater endoscopic image motion and worse image stability.
Contact information is provided by the study sponsor or research team.
Hitit University
Other
Comparison of Normal Ventilation and Low Tidal Volume Ventilation During Retrograde Intrarenal Surgery (RIRS) Using Video-Based Motion Index: A Randomized Controlled Trial
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