Clinical trial NCT05792670: Can High Ventilation Provide Higher Success Rates in Retrograde Intrarenal Surgery?
Official title: Can High Ventilation Mode Achieve Higher Success Rates in Retrograde Intrarenal Surgery? Single-Blind Randomized, Prospective, Single-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney; Mobile
Keywords: renal mobility
urinary stone
mechanic ventilation
success status
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided randomly by a computer-generated randomization table into two equal groups.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: perioperatively data of RIRS procedure according to different ventilatation modes
timeFrame: During the surgical procedure
measure: Complicatation of perioperatively during RIRS
timeFrame: During the surgical procedure
Secondary outcomes:
measure: Post operative success rates
timeFrame: At the postoperative first month of surgery
measure: Post operative complication
timeFrame: From postoperative first day to postoperative 1. month
Other outcomes:
Locations:
city: Tekirdag
country: Turkey
facility: Cagri Dogan
state: Please Select:
Study officials:
affiliation: Namik Kemal University
name: Cagri Dogan, Asst.Prof.
role: STUDY_CHAIR
affiliation: Namik Kemal University
name: Cenk Murat Yazici, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: