Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

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

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.

Study Overview

• Status: Completed
• Conditions: Oxygen Deficiency
• Intervention / Treatment: Behavioral: Mechanical ventilator-assisted ventilation

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Turkey
  • Pendik
    • Istanbul, Pendik, Turkey, 34899
      • Marmara University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric surgical patients aged 5-10 years scheduled for elective surgery.

Description

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
• Obesity

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; AutoFlow mechanical ventilation	Behavioral: Mechanical ventilator-assisted ventilation; After the intravenous anesthesia induction, mechanical ventilator-assisted ventilation with AutoFlow mode of the anesthesia machine (Draeger-Perseus) will be applied before intubation.
Group M; Manual ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIRS_-1	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	60 seconds before induction.
NIRS_0	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	At the start of anesthesia induction.
NIRS_0.5	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	30 seconds after the anesthesia induction.
NIRS_1	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	60 seconds after the anesthesia induction.
NIRS_1.5	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	90 seconds after the anesthesia induction.
NIRS_2	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	120 seconds after the anesthesia induction.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIRS_15	Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).	15 minutes after the anesthesia induction.

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Tumay Umuroglu, Prof. Dr., Marmara University Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 09.2022.277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No