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Completed

NCT Number: NCT05792670

Can High Ventilation Provide Higher Success Rates in Retrograde Intrarenal Surgery?

RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. Many surgeons prefer general anesthesia during RIRS to minimize respiration-related renal mobility. Standard mechanical ventilation settings were still inadequate to limit renal mobility and the surgeons tried to find the most effective ventilation mode to minimize renal mobility.

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Key information

Conditions

Kidney; Mobile Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cagri Dogan

Tekirdağ, Please Select:, 59100, Turkey (Türkiye)

About this study

A standard general anesthesia protocol is given to all patients by the same anesthesiologist. A Drager Primus (Germany) mechanic ventilator (MV) is preferred for general anesthesia. The MV will determine the tidal volume and respiration frequency according to the patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode is 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume will decrease to 6-8 mL/kg and the frequency will increase to 15-18 respirations/min. No changes are made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters. The ventilation mode of the mechanic ventilator (SV or HV) is determined via randomization software before the surgery. According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. A high ventilation mode is formed by increasing the respiration frequency and decreasing the study's tidal volume. The aim of the study was to evaluate the effect of this mode on the efficacy and safety of RIRS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who underwent RIRS with kidney stones older than18 y.o

Exclusion criteria

Patients younger than 18 years old Patients with a known respiratory disease Patients with a renal anomaly Proximal ureteral stones, or stones with multiple locations The patients who underwent previous ipsilateral percutaneous nephrolithotomy and/or open renal surgery were excluded from the study.

Treatment and study plan

Changing mechanic ventilatation parameters

Procedure

The tidal volume and respiration frequency were determined by the MV according to patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode was defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume was decreased to 6-8 mL/kg and the frequency was increased to 15-18 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters.

Primary outcomes

  1. perioperatively data of RIRS procedure according to different ventilatation modes

    Time frame: During the surgical procedure

    perioperatively data including e.g. operation time

  2. Complicatation of perioperatively during RIRS

    Time frame: During the surgical procedure

    The presence of perioperative bleeding, perioperative bleeding, ureteral perforation, bladder perforation, ureteral avulsion

Secondary outcomes

  1. Post operative success rates

    Time frame: At the postoperative first month of surgery

    The stone free status and residue stone volume according to CT

  2. Post operative complication

    Time frame: From postoperative first day to postoperative 1. month

    Postoperative complication status including urosepsis, fever, renal colic, flank pain, bleeding and stent migration etc.

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

Can High Ventilation Mode Achieve Higher Success Rates in Retrograde Intrarenal Surgery? Single-Blind Randomized, Prospective, Single-Center Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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