Assessment Through Transcutaneous Brain Oximetry (NIRS) of Two Preoxygenation Techniques (NCT04352049) | Clinical Trial Compass
CompletedNot Applicable
Assessment Through Transcutaneous Brain Oximetry (NIRS) of Two Preoxygenation Techniques
Spain53 participantsStarted 2012-04-15
Plain-language summary
Preoxygenation techniques is currently considered a standard of care, but how they influence cerebral oxygenation remains largely unknown. In this study, the investigators compare three minutes tidal volume breathing versus eight vital capacity, deep breaths (8DB) technique. Forty-eight patients scheduled for surgery under general anesthesia were included in a randomized study design. The main endpoints were arterial partial pressure of O2 (PaO2) and regional cerebral oxygen saturation (rScO2 ; INVOS TM -5100- C) which were measured at baseline (T1), end of pre-oxygenation (T2) and after desaturation during apnoea to 95% (T3).
Who can participate
Age range
18 Years – 65 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:
* Healthy adult patients scheduled for surgery under general anaesthesia with tracheal intubation
* ASA physical status 1
* aged between 18 and 65 years.
Exclusion Criteria:
* Baseline peripheral oxygen saturation (SpO2) of less than 95%,
* BMI \> 30 kg.m-2,
* cardiac, respiratory or brain diseases,
* previous or active smoking,
* predicted difficult airway,
* frontal sinusitis,
* cerebral vascular disorders,
* hemoglobin less than 13g.dL-1,
* low-quality rScO2 signal.
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
1
Cerebral regional oxygen saturation (rScO2)
Timeframe: Preoxygenation period, an average of 10 minutes
Trial details
NCT IDNCT04352049
SponsorComplexo Hospitalario Universitario de A Coruña