- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07705646
Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery (RIRS-VENT)
Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuna Ertürk, MD
- Phone Number: +905325010066
- Email: tunaerturk22@yahoo.com
Study Contact Backup
- Name: Hakan Emirkadı, MD
- Phone Number: +905322609367
- Email: suheylaatay81@gmail.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34668
- Sultan Abdulhamid Han Training and Research Hospital
-
Contact:
- Tuna Ertürk, MD
- Phone Number: +905325010066
- Email: tunaerturk22@yahoo.com
-
Contact:
- Hakan Emirkadı, MD
- Phone Number: 05322609367
- Email: hemirkadi@gmail.com
-
Principal Investigator:
- Tuna Ertürk, MD
-
Sub-Investigator:
- Hakan Emirkadı, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Ventilation
Patients will receive standard volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia.
|
Volume-controlled mechanical ventilation using standard ventilator settings during general anesthesia.
|
|
Experimental: Hypoventilation
Patients will receive hypoventilation with reduced tidal volume and respiratory rate during retrograde intrarenal surgery under general anesthesia.
|
Volume-controlled mechanical ventilation using reduced tidal volume and respiratory rate during general anesthesia.
|
|
Experimental: Intermittent Apnea Ventilation
Patients will receive intermittent apnea periods during selected surgical steps, in coordination with the surgeon.
|
Intermittent apnea periods applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.
|
|
Experimental: One-Lung Ventilation
Patients will receive one-lung ventilation during selected surgical steps, in coordination with the surgeon.
|
One-lung ventilation applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kidney Motion During Retrograde Intrarenal Surgery
Time Frame: During surgery
|
Kidney motion during surgery will be evaluated and compared among the four ventilation strategies.
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone-free Rate
Time Frame: Postoperative Day 30
|
Percentage of patients who are stone-free after retrograde intrarenal surgery.
|
Postoperative Day 30
|
|
Operative Time
Time Frame: During surgery
|
Total duration of surgery measured from the beginning to the end of the surgical procedure.
|
During surgery
|
|
Fluoroscopy Time
Time Frame: During surgery
|
Total fluoroscopy exposure time recorded during the procedure.
|
During surgery
|
|
Laser Activation Time
Time Frame: During surgery
|
Total duration of laser use during stone fragmentation.
|
During surgery
|
|
Perioperative Complications
Time Frame: Periprocedural
|
Occurrence of intraoperative and postoperative complications.
|
Periprocedural
|
|
Length of Hospital Stay
Time Frame: Periprocedural
|
Number of days of hospitalization.
|
Periprocedural
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tuna Ertürk, MD, University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Nephrolithiasis
- Therapeutics
- Airway Management
- Respiration, Artificial
- One-Lung Ventilation
Other Study ID Numbers
- 21-64
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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