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Clinical Trials/NCT05834608
NCT05834608
Completed
Not Applicable

Cerebral Regional Oxygenation with Manual Versus Mechanical Ventilator Assisted Ventilation During Intravenous Induction in Pediatric Patients

Marmara University1 site in 1 country51 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxygen Deficiency
Sponsor
Marmara University
Enrollment
51
Locations
1
Primary Endpoint
NIRS_-1
Status
Completed
Last Updated
last year

Overview

Brief Summary

Anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow to major organs. Moreover it can result in deoxygenation as well. During standard anesthesia induction the patient is manually ventilated with a circle-valve-mask system until the effect of muscle relaxant shows of. Near-infrared spectroscopy (NIRS) is a modification of a well-known peripheral pulse oxymetry that is used in the detection of the regional oxygen saturation (rSO2) in organs, including brain, liver, muscle, and intestines. In this study we will compare the regional oxygenation status of the patients during anesthesia induction in which either standard manual ventilation or mechanical ventilator-assisted ventilation was performed. AutoFlow(R) mode of Draeger-Perseus mechanical ventilator will be used for the ventilator-assisted ventilation.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
August 4, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ruslan Abdullayev

Assoc. Prof.

Marmara University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anaesthesiologists (ASA) physical status I-II

Exclusion Criteria

  • ASA III or above
  • Congenital or traumatic brain injury
  • Allergy to NIRS probe material
  • Cardiac or vascular disease, including heart failure or hypertension
  • Difficult mask ventilation and difficult intubation
  • Thoracic surgery
  • Head and neck surgery
  • Emergency surgery

Outcomes

Primary Outcomes

NIRS_-1

Time Frame: 60 seconds before induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_0.5

Time Frame: 30 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_1

Time Frame: 60 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_1.5

Time Frame: 90 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_2

Time Frame: 120 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_0

Time Frame: At the start of anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

Study Sites (1)

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