Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

Completed

• Conditions: Oxygen Deficiency
• Interventions: Behavioral: Mechanical ventilator-assisted ventilation

• Registration Number: NCT05834608
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-01-01
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-28
• Study Completion: 2023-08-04
• Status Verified: 2023-10
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Mechanical ventilator-assisted ventilation	AutoFlow mechanical ventilation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Marmara University School of Medicine; 🇹🇷 Istanbul, Pendik, Turkey