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NCT Number: NCT01835600

Transient Apnea During Flexible Ureteroscopic Lithotripsy

Respiration-related renal motion may reduce targeting stability during flexible ureteroscopic laser lithotripsy and thereby decrease lithotripsy efficiency. This single-center, three-arm randomized controlled trial evaluated whether transient apnea during active lithotripsy could improve lithotripsy efficiency while maintaining short-term physiologic safety. A total of 150 patients undergoing flexible ureteroscopic lithotripsy for renal stones were randomized in a 1:1:1 ratio to regular mechanical ventilation, small tidal-volume ventilation, or transient apnea. The primary outcome was active lithotripsy efficiency, defined as CT-based stone volume divided by active lithotripsy time. Physiologic safety was assessed using serial arterial blood gas measurements at baseline, 3, 6, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation, together with continuous intraoperative cardiopulmonary monitoring.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

About this study

Respiration-related renal motion is a common technical challenge during flexible ureteroscopic laser lithotripsy. Movement of the kidney and collecting system may reduce laser targeting stability, interrupt continuous lithotripsy, and decrease active lithotripsy efficiency. Ventilation strategies that reduce respiratory motion may therefore improve operative stability, but they must be evaluated together with physiologic safety.

This study was designed as a single-center, prospective, three-arm, parallel-group randomized controlled trial. Adult patients scheduled for elective flexible ureteroscopic laser lithotripsy for renal stones under general anesthesia were screened for eligibility. After informed consent and eligibility confirmation, participants were randomized in a 1:1:1 ratio to one of three intraoperative ventilation strategies: regular mechanical ventilation, small tidal-volume ventilation, or transient apnea during active laser lithotripsy.

In the regular mechanical ventilation group, standard controlled ventilation was maintained during lithotripsy. In the small tidal-volume ventilation group, a reduced tidal-volume strategy was used during the lithotripsy phase to decrease respiration-related renal motion while maintaining clinically acceptable oxygenation and ventilation. In the transient apnea group, apnea was initiated during active laser lithotripsy after adequate preoxygenation and confirmation of hemodynamic stability by the anesthesiologist. Apnea was discontinued if any prespecified safety criterion occurred, including SpO₂ <90%, systolic blood pressure >160 mmHg or <80 mmHg, heart rate <50 beats/min, obvious arrhythmia, hemodynamic instability, or any safety concern from the attending anesthesiologist.

The primary efficacy outcome was active lithotripsy efficiency, defined as CT-based stone volume divided by active lithotripsy time. Secondary outcomes included active lithotripsy time, total operative time, postoperative stone-free status, residual stone burden, physiologic changes on arterial blood gas analysis, protocol-defined apnea interruption, and postoperative complications. Stone-free status was assessed by CT, and non-stone-free status was defined as any residual fragment >2 mm. Arterial blood gas measurements were obtained at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 80 years.
  • Scheduled for elective flexible ureteroscopic laser lithotripsy for renal stones under general anesthesia.
  • Preoperative CT confirming renal stones suitable for flexible ureteroscopic lithotripsy.
  • Stone size ≥10 mm and <20 mm.
  • American Society of Anesthesiologists physical status I to III.
  • Ability to provide written informed consent.

Exclusion criteria

  • American Society of Anesthesiologists physical status IV or V.
  • Stone size <10 mm or ≥20 mm.
  • Multiple renal stones requiring a combined or alternative surgical strategy.
  • Radiolucent stone or inadequate radiographic assessment.
  • Uncontrolled urinary tract infection.
  • Reduced pulmonary function, including FEV1/FVC <70%, or other clinically relevant pulmonary dysfunction judged unsuitable for transient apnea.
  • Significant cardiopulmonary instability or anesthetic contraindication to transient apnea.
  • Pregnancy or planned pregnancy during the study period.
  • Planned combined procedure or alternative surgical strategy.
  • Incomplete preoperative assessment.
  • Declined participation after counselling.
  • Withdrawal of consent before randomization.

Treatment and study plan

Regular mechanical ventilation during flexible ureteroscopic lithotripsy

Other

Standard controlled mechanical ventilation was maintained during the active lithotripsy phase according to routine anesthetic practice.

Small tidal-volume ventilation during flexible ureteroscopic lithotripsy

Other

Controlled ventilation with a reduced tidal-volume strategy was applied during active lithotripsy under continuous anesthetic monitoring.

Transient apnea during flexible ureteroscopic lithotripsy

Other

Transient apnea was applied during active laser lithotripsy to reduce respiration-related renal motion. Apnea was initiated after adequate preoxygenation and confirmation of physiologic stability. Apnea was terminated if SpO₂ was <90%, systolic blood pressure was >160 mmHg or <80 mmHg, heart rate was <50 beats/min, obvious arrhythmia occurred, hemodynamic instability developed, or the attending anesthesiologist had any safety concern.

Primary outcomes

  1. Active lithotripsy efficiency

    Time frame: Intraoperative

    Active lithotripsy efficiency was defined as CT-based stone volume divided by active lithotripsy time. Stone volume was calculated from stone length, width, and depth using the ellipsoid formula. Active lithotripsy time was defined as the duration of active laser fragmentation or dusting and excluded ureteral access, endoscopic inspection, stent placement, and other non-lithotripsy procedural time.

Secondary outcomes

  1. Active lithotripsy time

    Time frame: Intraoperative

    Active lithotripsy time was defined as the duration of active laser fragmentation or dusting during flexible ureteroscopic lithotripsy.

  2. Total operative time

    Time frame: Intraoperative

    Total operative time was defined as the time from endoscope insertion to completion of the procedure.

  3. Stone-free status on postoperative day 1 CT

    Time frame: Postoperative day 1

    Stone-free status was assessed using CT on postoperative day 1. Non-stone-free status was defined as any residual fragment >2 mm.

  4. Arterial pH

    Time frame: Baseline to 3 minutes after resumption of ventilation

    Arterial pH was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.

  5. Arterial carbon dioxide tension

    Time frame: Baseline to 3 minutes after resumption of ventilation

    Arterial PaCO₂ was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.

  6. Arterial oxygen tension

    Time frame: Baseline to 3 minutes after resumption of ventilation

    Arterial PaO₂ was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.

  7. Arterial lactate

    Time frame: Baseline to 3 minutes after resumption of ventilation

    Arterial lactate was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.

  8. Base excess

    Time frame: Baseline to 3 minutes after resumption of ventilation

    Base excess was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation.

  9. Protocol-defined interruption of transient apnea

    Time frame: Intraoperative

    Protocol-defined interruption was recorded when transient apnea was discontinued because of SpO₂ <90%, systolic blood pressure >160 mmHg or <80 mmHg, heart rate <50 beats/min, obvious arrhythmia, hemodynamic instability, or anesthesiologist concern.

  10. Postoperative complications

    Time frame: Up to 3 months after surgery

    Postoperative complications were recorded and graded according to the Clavien-Dindo classification.

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Official study title

Transient Apnea to Stabilize Renal Motion During Flexible Ureteroscopic Lithotripsy: A Randomized Controlled Trial of Efficiency and Physiological Safety

Acronym: TA-fURS

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 19, 2013
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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