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Transient Apnea During Flexible Ureteroscopic Lithotripsy

NCT01835600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Renal Calculi
  • Kidney Stones

Interventions

OTHER

Regular mechanical ventilation during flexible ureteroscopic lithotripsy

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

OTHER

Small tidal-volume ventilation during flexible ureteroscopic lithotripsy

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

OTHER

Transient apnea during flexible ureteroscopic lithotripsy

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.

Sponsors & Collaborators

  • Chinese Medical Association

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2024-12-27
Completion
2025-04-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835600 on ClinicalTrials.gov