Kidney; Mobile
Conditions
Keywords
renal mobility, urinary stone, mechanic ventilation, success status
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.
Interventions
PROCEDUREChanging 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.
Sponsors
Namik Kemal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
The patients will be divided randomly by a computer-generated randomization table into two equal groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Post operative success rates | At the postoperative first month of surgery | The stone free status and residue stone volume according to CT |
Countries
Turkey (Türkiye)
Outcome results
None listed