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Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05834608
Enrollment
51
Registered
2023-04-28
Start date
2022-06-01
Completion date
2023-08-04
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Deficiency

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.

Interventions

BEHAVIORALMechanical 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NIRS_-160 seconds before induction.Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).
NIRS_0At the start of anesthesia induction.Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).
NIRS_0.530 seconds after the anesthesia induction.Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).
NIRS_160 seconds after the anesthesia induction.Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).
NIRS_1.590 seconds after the anesthesia induction.Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).
NIRS_2120 seconds after the anesthesia induction.Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026