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Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery

2026年6月19日 更新者: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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Çorum、トルコ(Türkiye)
        • 募集
        • Hitit University
        • コンタクト:
          • Ozgur Yagan, Professor

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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%.
他の名前:
  • Normal Tidal Volume Ventilation
実験的: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%.
他の名前:
  • Normal Tidal Volume Ventilation

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Motion Index During Retrograde Intrarenal Surgery
時間枠: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.
Intraoperative period, during a standardized 60-second video segment

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月29日

一次修了 (推定)

2026年8月15日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年6月8日

QC基準を満たした最初の提出物

2026年6月8日

最初の投稿 (実際)

2026年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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