CompletedNot Applicable

Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

Turkey (Türkiye)51 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range

5 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIRS_-1

Timeframe: 60 seconds before induction.

NIRS_0

Timeframe: At the start of anesthesia induction.

NIRS_0.5

Timeframe: 30 seconds after the anesthesia induction.

NIRS_1

Timeframe: 60 seconds after the anesthesia induction.

NIRS_1.5

Timeframe: 90 seconds after the anesthesia induction.

NIRS_2

Timeframe: 120 seconds after the anesthesia induction.

Trial details

NCT IDNCT05834608

SponsorMarmara University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-01

View on ClinicalTrials.gov More Oxygen Deficiency trials