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

Namik Kemal University

Status: Completed

Conditions: Kidney; Mobile

Treatments: Procedure: Changing mechanic ventilatation parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT05792670

2022.179.10.03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 86 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Standard Ventilatation Mode

Active Comparator group

Description:

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

Treatment:

Procedure: Changing mechanic ventilatation parameters

High Ventilatation Mode

Active Comparator group

Description:

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

Treatment:

Procedure: Changing mechanic ventilatation parameters