Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery
ConditionRenal Calculi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitit University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients younger than 18 years
Pregnancy
Emergency surgery
Severe chronic obstructive pulmonary disease, severe restrictive pulmonary disease, or preoperative hypercapnia
Trial design
Design model
Parallel
Treatments tested in this trial
low tidal volume ventilation
Procedure/SurgeryParticipants 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%.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Normal Tidal Volume VentilationActive comparator 1 intervention
Group B: Low Tidal Volume VentilationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Motion Index During Retrograde Intrarenal Surgery
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.
Time frame
Intraoperative period, during a standardized 60-second video segmentSponsors and contacts
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Source ClinicalTrials.gov