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Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

NCT ID: NCT05834608

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-08-04

Brief Summary

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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.

Detailed Description

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Conditions

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Oxygen Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group M

Manual ventilation

No interventions assigned to this group

Group A

AutoFlow mechanical ventilation

Mechanical ventilator-assisted ventilation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Ruslan Abdullayev

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tumay Umuroglu, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Marmara University Department of Anesthesiology and Reanimation

Locations

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Marmara University School of Medicine

Istanbul, Pendik, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2022.277

Identifier Type: -

Identifier Source: org_study_id