Effect of Tidal Volume on fURS Parameters

NCT07304297 | Completed

• 1 other identifier: MAR.UAD.0026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective clinical trial is to evaluate how intraoperative tidal volume settings affect surgical parameters and outcomes in adult patients undergoing flexible ureteroscopy (fURS) for kidney stones. The participant population includes patients over 18 years of age with unilateral, single renal stones located in the upper/middle calyx or renal pelvis. This study aims to answer are: Does intraoperative tidal volume influence operative time and surgical efficiency during fURS? Does tidal volume affect laser energy use, lasing efficiency, stone-free rates, and complication rates (infection or bleeding)? The investigators will compare two groups based on tidal volume recorded during anaesthesia: Group 1: Low tidal volume (\< 500 mL) Group 2: Standard tidal volume (≥ 500 mL) to determine whether tidal volume differences impact surgical performance and postoperative outcomes. Participants will: Undergo fURS performed under general anaesthesia with standard ASA monitoring, including ETCO₂ and TOF monitoring. Have their respiratory parameters (tidal volume, peak airway pressure, PEEP, respiratory rate, ETCO₂) and surgical data (operative time, laser settings, fluoroscopy use, stone-free status) recorded during and after surgery.

Conditions

Urolithiasis; Tidal Volume; Flexible Ureteroscopy

Outcome Measures

Primary Outcomes (1)

• Correlation Between Intraoperative Respiratory Parameters and Surgical Outcomes

  Respiratory parameter measured: Tidal Volume (mL/kg) Measurement tool: Anaesthesia ventilator/monitoring system Unit: milliliters per kilogram (mL/kg) Surgical outcomes assessed: Stone-free rate (%), assessed by postoperative non-contrast CT scan Operative time (minutes), recorded from surgical logs Complications, graded using the Clavien-Dindo classification The objective is to determine the statistical correlation between tidal volume and each of these surgical outcomes.

  2 months

Secondary Outcomes (1)

• Correlation Between Intraoperative Respiratory Parameters and Seconder Outcomes

  2 months

Study Arms (2)

Low Tidal Volume

ACTIVE COMPARATOR

Procedure: Flexible Ureteroscopy

Normal Tidal Volume

PLACEBO COMPARATOR

Procedure: Flexible Ureteroscopy

Interventions

Flexible Ureteroscopy PROCEDURE

Between October 2025 and December 2025, Patients who underwent fURS surgery in our clinic, with the surgical indication determined according to the EAU guidelines, were included in the study. Patients over 18 years of age with unilateral, single stones located in the upper or middle calyx or in the renal pelvis were included in the study. Patients with chronic obstructive pulmonary disease, pregnancy, a history of abdominal, retroperitoneal, or thoracic surgery, kidney anomalies, or stones located in the lower calyx were excluded.

Low Tidal Volume; Normal Tidal Volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Unilateral, single kidney stones located in the upper or middle calyx or in the renal pelvis

You may not qualify if:

• Chronic obstructive pulmonary disease (COPD)
• Pregnancy
• History of abdominal, retroperitoneal, or thoracic surgery
• Kidney anomalies
• Stones located in the lower calyx

Sponsors & Collaborators

• Tarik Emre Sener: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 26, 2025
• Study Start: September 1, 2025
• Primary Completion: November 23, 2025
• Study Completion: November 24, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)