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PostoperAtIve Oxygen suppLy to reduce tempOrary deSaturation in patients after non-cardiac surgery, a prospective, randomised controlled trial (AIOLOS trial)
EU CTIS ID: 2024-514285-39-00
What this study is testing
To investigate the difference in time weighted average (TWA) of peripheral oxygen saturation (SpO2) below 90% (SpO2-TWA<90), measured by pulse oximetry, within the first 2 days after surgery between the two groups (Group A: 3 L min^-1 O2 via nasal cannula or Group B: Standard of care)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Elective non-cardiac surgery (only including general surgery and urological surgery);
- At least one preoperative overnight stay and two planned postoperative overnights;
- ≥ 60 years of age;
- At risk for postoperative complications due to postoperative desaturation events, defined as at least one of the following circumstances: a) preoperatively measured hsTnT > 25 ng/L, b) preoperatively measured NT-proBNP ≥ 200 ng/L, c) history of coronary artery disease, d) history of peripheral artery disease (PAD), e) 75 years of age or older, f) history of transient ischemic attack (TIA) or stroke, g) current smoking or cessation of smoking within 2 years, h) diabetes (any type) or currently taking any anti-diabetic drug, i) hyperlipidemia, j) history of hypertension or currently taking any antihypertensive drug, k) atrial fibrillation;
- Surgery conducted under general anaesthesia AND
- Provide written informed consent.
You likely can't join if
- Intensive care unit (ICU) / intermediate care unit (IMC) patients undergoing surgery or planned postoperative telemetry or other continuous monitoring of vital parameters
- Conditions requiring respiratory support with NIV devices, long-time oxygen therapy (LTOT) or supplementary O2;
- Respiratory tract infection the last two weeks before surgery;
- Severe pre-existing chronic obstructive pulmonary disease (COPD; severe defined as GOLD III and IV) or
- Ongoing or previous chemotherapy with bleomycin.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.