NCT05834608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2023

Completed
Last Updated

December 31, 2024

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

April 4, 2023

Last Update Submit

December 28, 2024

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (6)

  • 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.

Study Arms (2)

Group M

Manual ventilation

Group A

AutoFlow mechanical ventilation

Behavioral: Mechanical ventilator-assisted ventilation

Interventions

Mechanical ventilator-assisted ventilationBEHAVIORAL

After the intravenous anesthesia induction, mechanical ventilator-assisted ventilation with AutoFlow mode of the anesthesia machine (Draeger-Perseus) will be applied before intubation.

Group A

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tumay Umuroglu, Prof. Dr.

    Marmara University Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 28, 2023

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

August 4, 2023

Last Updated

December 31, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)