Cerebral Regional Oxygenation With Manual Versus AutoFlow Ventilation

Oxygen Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05834608
• Other study ID #: 09.2022.277
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: August 4, 2023

Study information

• Verified date: October 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 4, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

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