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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Kidney; Mobile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided randomly by a computer-generated randomization table into two equal groups.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. The surgeons will perform the RIRS without knowing the type of ventilation mode.

Study Groups

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Standard Ventilatation Mode

SV mode is defined according to the mechanical ventilator parameters (patients' age and weight) Standard ventilation mode is defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters

Group Type ACTIVE_COMPARATOR

Changing mechanic ventilatation parameters

Intervention Type 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.

High Ventilatation Mode

Hv mode is defined as the tidal volume decreased to 6-8 mL/kg and the frequency is 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

Group Type ACTIVE_COMPARATOR

Changing mechanic ventilatation parameters

Intervention Type 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.

Interventions

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Changing mechanic ventilatation parameters

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No