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

NCT ID: NCT06320743

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-11-06

Brief Summary

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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.

Detailed Description

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The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) I-III risk group patients, aged between 2 and 12 years, who will under go general anesthesia with a surgical procedure time of 1 hour or more, and who will undergo pediatric surgery, orthopedic and urological surgery, will be included in the study. Preoperative patients' age, gender, height, weight, ASA score and operation type information will be recorded. Patients will be randomized by the sealed envelope method and divided into 2 groups: Low-Flow Anesthesia (LFA) and High-Flow Anesthesia (HFA) groups.

Two groups will undergo NIRS monitoring alongside routine ASA monitoring. 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 basal values will be noted.

Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group LFA

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.

Group Type ACTIVE_COMPARATOR

NIRS ,Ventilation parameters

Intervention Type 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.

Oxygen concentration

Intervention Type 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 HFA

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.

Group Type ACTIVE_COMPARATOR

NIRS ,Ventilation parameters

Intervention Type 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.

Interventions

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NIRS ,Ventilation parameters

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.

Intervention Type DEVICE

Oxygen concentration

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%

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Şengül Özmert

Assoc. Prof. MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sengül Özmert

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Low Flow Anaesthesia And NIRS

Identifier Type: -

Identifier Source: org_study_id