Evaluation of Renal Oxygenation by NIRS in Pediatric Endourologic Stone Surgery

NCT06110247 | Completed

• 1 other identifier: NIRS
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare renal oxygenation levels in retrograde intrarenal surgery (RIRS) and ureteroscopy (URS) procedures with a control group. Additionally, it seeks to determine if there is a connection between postoperative infection parameters and intraoperative renal oxygenation measurements.

Conditions

Renal Stone; Kidney; Complications; Ureter Stone; Renal Oxygenation

Keywords

Near infrared spectroscopy; Pediatric; Renal oxygenation; Endourologic stone surgery; infectious complication

Outcome Measures

Primary Outcomes (1)

• Near infrared spectroscopy (NIRS)

  Rretrograde intrarenal surgery (RIRS), ureteroscopy (URS) and hypospadias operations, renal oxygen level will be measured via NIRS monitor.

  NIRS values will be documented immediately prior to induction and every 5 minutes until recovery from anesthesia.

Secondary Outcomes (3)

• Infection parameters

  Preoperative and postoperative 24th hour

• Infection parameters

  Preoperative and postoperative 24th hour

• Infection parameters

  Preoperative and postoperative 24th hour

Study Arms (3)

Group R

Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded .

Device: NIRS; Other: Taking a blood sample

Group U

Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded .

Device: NIRS; Other: Taking a blood sample

Group H

The study involves continuous NIRS monitoring in addition to routine ASA monitoring. To establish the initial value of regional oxygen saturation (rSO2), renal NIRS probes will be positioned using ultrasonography, and an average of three measurements will be taken. Throughout the procedure, NIRS data, along with pulse oximetry and hemodynamic data, will be recorded at 5-minute intervals until the patient recovers from anesthesia just prior to induction. Significant changes in NIRS values will be determined if a decrease of 20% or more compared to the baseline measurement is observed. Anesthesia and surgery times will also be recorded.

Device: NIRS

Interventions

NIRS DEVICE

After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value.

Group H; Group R; Group U

Taking a blood sample OTHER

Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded.

Group R; Group U

Eligibility Criteria

• Age: 1 Year - 18 Years
• Gender Eligibility Details: Due to the patient population of the hypospadias operation, Group H will consist of only male patients.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ASA I-III class between the ages of 1-18, patients who will undergo RIRS and URS surgery under standard general anesthesia, as well as patients who will undergo hypospadias surgery (without a history of stones or kidney problems).

You may qualify if:

• years ASA I-III class,
• Patients who will undergo RIRS, URS and Hypospadias surgeries under standard general anesthesia.
• Patients whose informed consent form is approved by their parents will be included in the study.

You may not qualify if:

• Exclusio criteria were the history of renal failure, renal tumors, infection of the perirenal region; receiving colloid or blood transfusion, having abscess, body mass index (BMI) not in the normal limits (≤3% or ≥97%)
• Patients whose parents do not approve the informed consent form will not be included in the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nephrolithiasis; Ureterolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Ureteral Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: November 3, 2023
• Primary Completion: March 7, 2024
• Study Completion: April 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)