Can High Ventilation Provide Higher Success Rates in Retrograde Intrarenal Surgery?
- Conditions
- Kidney; Mobile
- Interventions
- Procedure: Changing mechanic ventilatation parameters
- Registration Number
- NCT05792670
- Lead Sponsor
- Namik Kemal University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Patients who underwent RIRS with kidney stones older than18 y.o
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Ventilatation Mode Changing mechanic ventilatation parameters 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 Standard Ventilatation Mode Changing mechanic ventilatation parameters 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
- Primary Outcome Measures
Name Time Method perioperatively data of RIRS procedure according to different ventilatation modes During the surgical procedure perioperatively data including e.g. operation time
Complicatation of perioperatively during RIRS During the surgical procedure The presence of perioperative bleeding, perioperative bleeding, ureteral perforation, bladder perforation, ureteral avulsion
- Secondary Outcome Measures
Name Time Method Post operative success rates At the postoperative first month of surgery The stone free status and residue stone volume according to CT
Post operative complication From postoperative first day to postoperative 1. month Postoperative complication status including urosepsis, fever, renal colic, flank pain, bleeding and stent migration etc.
Trial Locations
- Locations (1)
Cagri Dogan
🇹🇷Tekirdag, Please Select:, Turkey