Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433, China
NCT Number: NCT01835600
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200433, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard controlled mechanical ventilation was maintained during the active lithotripsy phase according to routine anesthetic practice.
Controlled ventilation with a reduced tidal-volume strategy was applied during active lithotripsy under continuous anesthetic monitoring.
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.
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.
Time frame: Intraoperative
Active lithotripsy time was defined as the duration of active laser fragmentation or dusting during flexible ureteroscopic lithotripsy.
Time frame: Intraoperative
Total operative time was defined as the time from endoscope insertion to completion of the procedure.
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.
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.
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.
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.
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.
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.
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.
Time frame: Up to 3 months after surgery
Postoperative complications were recorded and graded according to the Clavien-Dindo classification.
Chinese Medical Association
Network
Transient Apnea to Stabilize Renal Motion During Flexible Ureteroscopic Lithotripsy: A Randomized Controlled Trial of Efficiency and Physiological Safety
Acronym: TA-fURS
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