CompletedNot Applicable

Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation

Turkey (Türkiye)64 participantsStarted 2023-02-15

Plain-language summary

The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses. The main question it aims to answer is that how high PEEP level effects the regional cerebral oxygen saturation in patients with high intracranial pressure due to mass effect. Patients will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O). Researchers will compare the changes of regional cerebral oxygen saturations between two groups by near infra-red spectroscopy.

Who can participate

Age range

18 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: * Older than 18 years * American Society of Anesthesiologists physical status classification system (ASA) I and II * Patients scheduled for elective craniotomy * Patients with supratentorial mass Exclusion Criteria: * Hemoglobin concentration lower than 9 mg/dL * Uncontrolled hypertension * Congestive heart failure * Severe chronic obstructive lung disease * Cerebrovascular disease * Pulmonary edema * History of carotis surgery or stenosis of carotid artery * Unstable hemodynamics * Pregnancy * Skin reaction to the NIRS sensor * Patient's refusal

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

regional cerebral oxygen saturation (SrO2) period 1

Timeframe: Pre-induction

regional cerebral oxygen saturation (SrO2) period 2

Timeframe: Up to 5 minutes after anethesia induction

regional cerebral oxygen saturation (SrO2) period 3

Timeframe: From skull-pinning to final head position

regional cerebral oxygen saturation (SrO2) period 4

Timeframe: Just before dura opening

regional cerebral oxygen saturation (SrO2) period 5

Timeframe: Up to 5 minutes of dura opening

regional cerebral oxygen saturation (SrO2) period 6

Timeframe: During surgical resection

regional cerebral oxygen saturation (SrO2) period 7

Timeframe: Up to 5 minutes of dura closure

Trial details

NCT IDNCT05961917

SponsorBozyaka Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-15

View on ClinicalTrials.gov More Regional Cerebral Oxygen Saturation trials