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

Study Overview
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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.

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.

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

Conditions
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Kidney; Mobile

Intervention / Treatment
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* Procedure: Changing mechanic ventilatation parameters


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be divided randomly by a computer-generated randomization table into two equal groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Ventilatation Mode<br>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 | Procedure: Changing mechanic ventilatation parameters<br>* 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.<br>|
| Active Comparator: High Ventilatation Mode<br>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 | Procedure: Changing mechanic ventilatation parameters<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperatively data of RIRS procedure according to different ventilatation modes | perioperatively data including e.g. operation time | During the surgical procedure | 
| Complicatation of perioperatively during RIRS | The presence of perioperative bleeding, perioperative bleeding, ureteral perforation, bladder perforation, ureteral avulsion | During the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative success rates | The stone free status and residue stone volume according to CT | At the postoperative first month of surgery | 
| Post operative complication | Postoperative complication status including urosepsis, fever, renal colic, flank pain, bleeding and stent migration etc. | From postoperative first day to postoperative 1. month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal mobility, urinary stone, mechanic ventilation, success status