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

8 giugno 2026 aggiornato da: Sibel Onen Ozdemir, Hitit University

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Çorum, Turchia (Türkiye)
        • Reclutamento
        • Hitit university
        • Contatto:
          • Ozgur Yagan, Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Normal Tidal Volume Ventilation
Participants in this group will receive standard mechanical ventilation after induction of general anesthesia and endotracheal intubation during retrograde intrarenal surgery. 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%.
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%.
Altri nomi:
  • Normal Tidal Volume Ventilation
Sperimentale: Low Tidal Volume Ventilation
Participants in this group will receive low tidal volume mechanical ventilation after induction of general anesthesia and endotracheal intubation during retrograde intrarenal surgery. Tidal volume will be set at 4-6 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%.
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%.
Altri nomi:
  • Normal Tidal Volume Ventilation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Motion Index During Retrograde Intrarenal Surgery
Lasso di tempo: Intraoperative period, during a standardized 60-second video segment
Mean 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. Consecutive video frames will be analyzed using a phase-correlation-based image registration method. Horizontal and vertical displacement components between consecutive frames will be used to generate the Motion Index time series, and the mean value will be used as the primary measure of endoscopic image motion.
Intraoperative period, during a standardized 60-second video segment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 aprile 2026

Completamento primario (Stimato)

15 agosto 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be publicly shared due to privacy, confidentiality, and institutional ethical restrictions. De-identified data may be made available from the principal investigator upon reasonable request and with appropriate institutional permission.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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