NCT07705646

Brief Summary

This randomized clinical trial will compare four ventilation strategies during retrograde intrarenal surgery performed under general anesthesia. The study aims to determine whether reducing respiratory-related kidney movement improves surgical success and decreases perioperative complications. Eighty adult patients will be randomly assigned to standard ventilation, hypoventilation, intermittent apnea ventilation, or one-lung ventilation. Surgical outcomes and perioperative complications will be compared between groups.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

July 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 5, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Retrograde Intrarenal SurgeryRIRSMechanical VentilatioGeneral AnesthesiaKidney Motion

Outcome Measures

Primary Outcomes (1)

  • Kidney Motion During Retrograde Intrarenal Surgery

    Kidney motion during surgery will be evaluated and compared among the four ventilation strategies.

    During surgery

Secondary Outcomes (6)

  • Stone-free Rate

    Postoperative Day 30

  • Operative Time

    During surgery

  • Fluoroscopy Time

    During surgery

  • Laser Activation Time

    During surgery

  • Perioperative Complications

    Periprocedural

  • +1 more secondary outcomes

Study Arms (4)

Standard Ventilation

ACTIVE COMPARATOR

Patients will receive standard volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia.

Procedure: Standard Ventilation

Hypoventilation

EXPERIMENTAL

Patients will receive hypoventilation with reduced tidal volume and respiratory rate during retrograde intrarenal surgery under general anesthesia.

Procedure: Hypoventilation

Intermittent Apnea Ventilation

EXPERIMENTAL

Patients will receive intermittent apnea periods during selected surgical steps, in coordination with the surgeon.

Procedure: Intermittent Apnea Ventilation

One-Lung Ventilation

EXPERIMENTAL

Patients will receive one-lung ventilation during selected surgical steps, in coordination with the surgeon.

Procedure: One-Lung Ventilation

Interventions

Volume-controlled mechanical ventilation using standard ventilator settings during general anesthesia.

Standard Ventilation

Volume-controlled mechanical ventilation using reduced tidal volume and respiratory rate during general anesthesia.

Hypoventilation

Intermittent apnea periods applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.

Intermittent Apnea Ventilation

One-lung ventilation applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.

One-Lung Ventilation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years. ASA physical status I-III. Scheduled for elective RIRS/RIRC under general anesthesia. No obstructive or restrictive pulmonary disease. No history of pneumothorax. No pulmonary mass or other significant respiratory disease. Normal coagulation parameters and not receiving antithrombotic therapy. No active urinary tract infection. Written informed consent.

You may not qualify if:

  • Age \<18 or \>75 years. ASA IV. Obstructive or restrictive pulmonary disease. History of pneumothorax. Pulmonary mass or significant respiratory disease. Receiving antithrombotic therapy or abnormal coagulation. Active urinary tract infection or urinary tract anatomical abnormality. Refusal or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasis

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Officials

  • Tuna Ertürk, MD

    University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Emirkadı, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of four parallel ventilation strategy groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 15, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available to protect participant confidentiality.

Locations