CompletedNot Applicable

Perioperative Hyperoxia vs Normoxia Biomarker Trial

Turkey (Türkiye)76 participantsStarted 2017-07-01

Plain-language summary

This single-center randomized interventional study evaluated the biological effects of two perioperative oxygen strategies in adults undergoing elective laparoscopic lower abdominal surgery under standardized general anesthesia. Participants were assigned to receive either normoxia (FiO2 0.35) or hyperoxia (FiO2 0.80) after intubation and throughout the intraoperative period. The study assessed perioperative changes in circulating biomarkers related to pulmonary epithelial stress, endothelial glycocalyx injury, oxidative stress, and inflammation, together with blood gas and hemodynamic parameters. The study was completed before registration and is being registered retrospectively.

Who can participate

Age range

18 Years – 70 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: * Adults aged 18 to 70 years * Scheduled for elective laparoscopic lower abdominal surgery * Expected surgery duration of at least 90 minutes * ASA physical status I to III * Body mass index 18.5 to 35 kg/m2 * Planned management under standardized general anesthesia with volume-controlled ventilation Exclusion Criteria: * Known chronic pulmonary disease, including chronic obstructive pulmonary disease or asthma requiring regular medication * Baseline peripheral oxygen saturation below 92% on room air * Significant cardiovascular instability * Severe hepatic or renal dysfunction * Active infection or systemic inflammatory disease * Use of systemic corticosteroids or immunosuppressive therapy * Pregnancy * Inability to provide informed consent * Anticipated difficult airway * Expected need for postoperative mechanical ventilation

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

Concentration of syndecan-1

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of sialic acid

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of surfactant protein-A

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of ischemia-modified albumin

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of TNF-alpha

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of total protein

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Trial details

NCT IDNCT07525661

SponsorIstanbul University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-01

View on ClinicalTrials.gov More Hyperoxia trials

Plain-language summary

Who can participate

Age range

18 Years – 70 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.

What they're measuring

Concentration of syndecan-1

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of sialic acid

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of surfactant protein-A

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of ischemia-modified albumin

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of TNF-alpha

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Concentration of total protein

Timeframe: 10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation