Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric

NCT06320743 | Completed

• 1 other identifier: Low Flow Anaesthesia And NIRS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur.

Conditions

Child, Only; Inhalation; Vapor; Anesthesia; Cerebral Oxygenation; Cerebral Hypoxia; Peripheral Oxygenation

Keywords

Near Infrared Spectroscopy; Low Flow Sevoflurane Anaesthesia; Pediatric; Cerebral and Peripheral Oxygenation

Outcome Measures

Primary Outcomes (1)

• Near infrared spectroscopy (NIRS)

  Cerebral and peripheral oxygenation will be measured with a NIRS device at low flow and high flow in pediatric patients whose surgical procedure duration is 60 minute or more and who will undergo pediatric surgery, orthopedic and urological surgery under general anesthesia.

  0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

Secondary Outcomes (8)

• Ventilation parameters

  0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

• Ventilation parameters

  0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

• Ventilation parameters

  0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

• Ventilation parameters

  0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

• Ventilation parameters

  0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

Study Arms (2)

Group LFA

ACTIVE COMPARATOR

NIRS probe will be attached to the inner surface of the forearm and cerebral right-left frontotemporal region and the values will be noted. Standard ASA monitoring and induction will be performed. Fresh gas flow will be 4 lt/min, 50% oxygen/air mixture, sevoflurane vaporizer will be turned on at 4%, continue for 10 minutes and then fresh gas flow will be reduced to 0.8 lt/min, sevoflurane the MAK value will be adjusted to be between 0.9-1.1. Alarm limits appropriate to the patient's weight will be determined for all patients, the lower limit of inspired O2 will be set as 30%, the upper limit of inspired CO2 will be set as 5mmHg. If the inspired O2 value drops below 30%, the pulse oximeter peripheral SpO2 drops below 97, and the NIRS values drop by 20%, the oxygen concentration will be increased by 10%. The sevoflurane vaporizer will be turned off 10 minutes before the end of the operation. When the extubation criteria are met, the patient will be extubated.

Device: NIRS ,Ventilation parameters; Device: Oxygen concentration

Group HFA

ACTIVE COMPARATOR

NIRS probe will be attached to the inner surface of the forearm and cerebral right-left frontotemporal region and the values will be noted. Standard ASA monitoring and induction will be performed.Fresh gas flow will be 3lt/min, 50% oxygen/air mixture, and the sevoflurane vaporizer will be turned on at 3%, sevoflurane the MAK value will be adjusted to be between 0.9-1.1. The sevoflurane vaporizer will be turned off the end of the operation. When the extubation criteria are met, the patient will be extubated.

Device: NIRS ,Ventilation parameters

Interventions

NIRS ,Ventilation parameters DEVICE

NIRS ,Ventilation parameters : Until the patient is taken to the operating table and leaves the operating table routine monitoring parameters, BIS values ,cerebral and peripheral NIRS values, until the patient is intubated and extubated ventilation parameters These parameters; 0. min (before induction), 1. min after induction, pre-post intubation, 5. min, 10. min, 20. min, 30. min, 45. min, 60. min, 90. min after connecting to the ventilator. It will then be noted at 1 hour intervals, and finally at the 5th minute after extubation.

Group HFA; Group LFA

Oxygen concentration DEVICE

Oxygen concentration : Alarm limits appropriate to the patient's weight will be determined for all patients, the lower limit of inspired O2 will be set as 30%, the upper limit of inspired CO2 will be set as 5mmHg. If the inspired O2 value drops below 30%, the pulse oximeter peripheral SpO2 drops below 97, and the NIRS values drop by 20%, the oxygen concentration will be increased by 10%

Group LFA

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 2-12 years of age, those who are planned to undergo pediatric surgery, orthopedic and urological surgery, and whose procedure time is 1 hour or more
• ASA I-III risk group
• Patients who agreed to be included in the study
• Patients whose informed consent form is approved by their parents will be included in the study.

You may not qualify if:

• Patients who do not want to participate in the study
• Patients with ASA score above III
• ASA III patients with decompensated cardiac and pulmonary disease
• Patients with neurological sequelae
• Cases with an operation duration of less than 1 hour
• Patients with contraindications to the use of any anesthetic drugs
• Patients for whom low-flow anesthesia is contraindicated
• Smoke and gas poisoning
• Malignant Hyperthermia
• Septic Shock
• CO2 absorbent depletion
• Insufficient oxygen monitoring
• Laparoscopic surgeries
• Patients who develop unexpected intra-operative surgical complications
• 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

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration; Hypoxia, Brain

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Sengül Özmert

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Model Details: Cerebral NIRS probe will be attached to the right and left frontotemporal region, and a peripheral NIRS probe will be attached to the inner surface of the forearm and the values will be noted.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 20, 2024
• Study Start: March 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 6, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)