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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Mechanical Ventilation | Active Comparator | Participants received regular mechanical ventilation during flexible ureteroscopic laser lithotripsy under general anesthesia. |
|
| Small Tidal-Volume Ventilation | Active Comparator | Participants received small tidal-volume controlled ventilation during active flexible ureteroscopic laser lithotripsy to reduce respiration-related renal motion while maintaining clinically acceptable oxygenation and ventilation. |
|
| Transient Apnea | Experimental | Participants underwent transient apnea during active flexible ureteroscopic laser lithotripsy after adequate preoxygenation and confirmation of physiologic stability by the anesthesiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular mechanical ventilation during flexible ureteroscopic lithotripsy | Other | Standard controlled mechanical ventilation was maintained during the active lithotripsy phase according to routine anesthetic practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Active lithotripsy efficiency | 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. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Active lithotripsy time | Active lithotripsy time was defined as the duration of active laser fragmentation or dusting during flexible ureteroscopic lithotripsy. | Intraoperative |
| Total operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital, Naval Medical University | Shanghai | Shanghai Municipality | 200433 | China |
Individual participant data will not be publicly shared because the dataset contains patient-level perioperative, imaging, and physiologic monitoring data, and public sharing was not included in the original informed consent. Deidentified data underlying the published results may be made available from the corresponding investigator upon reasonable request and after institutional ethics approval.
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Participants were randomized in a 1:1:1 ratio to regular mechanical ventilation, small tidal-volume ventilation, or transient apnea during flexible ureteroscopic laser lithotripsy.
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The surgeon and anesthesiology team were not masked because the assigned ventilation strategy was apparent during the procedure. Postoperative CT images were assessed by outcome assessors who were not involved in the intraoperative ventilation protocol and were masked to group allocation whenever feasible.
| 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. |
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| 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. |
|
Total operative time was defined as the time from endoscope insertion to completion of the procedure.
| Intraoperative |
| Stone-free status on postoperative day 1 CT | Stone-free status was assessed using CT on postoperative day 1. Non-stone-free status was defined as any residual fragment >2 mm. | Postoperative day 1 |
| Arterial pH | Arterial pH was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation. | Baseline to 3 minutes after resumption of ventilation |
| Arterial carbon dioxide tension | Arterial PaCO₂ was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation. | Baseline to 3 minutes after resumption of ventilation |
| Arterial oxygen tension | Arterial PaO₂ was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation. | Baseline to 3 minutes after resumption of ventilation |
| Arterial lactate | Arterial lactate was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation. | Baseline to 3 minutes after resumption of ventilation |
| Base excess | Base excess was measured at baseline, 3 minutes, 6 minutes, and 9 minutes during the lithotripsy phase and 3 minutes after resumption of ventilation. | Baseline to 3 minutes after resumption of ventilation |
| Protocol-defined interruption of transient apnea | 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. | Intraoperative |
| Postoperative complications | Postoperative complications were recorded and graded according to the Clavien-Dindo classification. | Up to 3 months after surgery |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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