PostoperAtIve Oxygen suppLy to reduce tempOrary deSaturation in patients after non-cardiac surgery, a prospective, randomised controlled trial (AIOLOS trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

19 Mar 2025 → ongoing

Decision date (initial)

2024-10-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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)

Secondary objectives 4

1. To investigate the difference in SpO2-TWA<90, measured by pulse oximetry, in patients either receiving 3 L min^-1 O2 via nasal cannula or standard of care within the first 24h after surgery between the two groups.
2. To investigate the difference in the quality of recovery-15 questionnaire in German (QoR-15GE) and sleep quality (as assessed in QoR-15GE) on the first day after surgery between the two groups.
3. To investigate the difference in the incidence of delirium between the two groups within the first 2 days after surgery, measured by a 3-minute diagnostic assessment for delirium (3D-CAM).
4. To investigate the difference in days at home within 30 days after surgery (DAH30) between the two groups.

Conditions and MedDRA coding

risk for postoperative complications after general surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Elective non-cardiac surgery (only including general surgery and urological surgery);
2. At least one preoperative overnight stay and two planned postoperative overnights;
3. ≥ 60 years of age;
4. 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;
5. Surgery conducted under general anaesthesia AND
6. Provide written informed consent.

Exclusion criteria 5

1. Intensive care unit (ICU) / intermediate care unit (IMC) patients undergoing surgery or planned postoperative telemetry or other continuous monitoring of vital parameters
2. Conditions requiring respiratory support with NIV devices, long-time oxygen therapy (LTOT) or supplementary O2;
3. Respiratory tract infection the last two weeks before surgery;
4. Severe pre-existing chronic obstructive pulmonary disease (COPD; severe defined as GOLD III and IV) or
5. Ongoing or previous chemotherapy with bleomycin.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. SpO2-TWA<90 in the first two days after surgery, measured using pulse oximetry.

Secondary endpoints 4

1. SpO2-TWA<90 in the first 24h after surgery, measured using pulse oximetry.
2. Score of the quality of recovery using QoR-15GE questionnaire in the evening of the first postoperative day.
3. Incidence of delirium using 3D-CAM on the first two days after surgery.
4. Incidence of surgical site infection documented in the hospital records and follow-up call after 30 days.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Coordination Center for Clinical Trials

Public contact point

Organisation

Medical University Of Graz

Contact name

Coordination Center for Clinical Trials

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications