Skip to main content
OpenTrials
Completed

NCT Number: NCT05834608

Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oxygen Deficiency Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilator-assisted ventilation

Behavioral

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

Primary outcomes

  1. NIRS_-1

    Time frame: 60 seconds before induction.

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

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2023
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.