Oxygen for Postoperative desaturation (hypoxaemia) | Risk of postoperative complications after general surgery | Risk of postoperative complications after urological surgery

Inclusion criteria

• {"criterion_text":"- Elective non-cardiac surgery (only including general surgery and urological surgery);"}
• {"criterion_text":"- At least one preoperative overnight stay and two planned postoperative overnights;"}
• {"criterion_text":"- ≥ 60 years of age;"}
• {"criterion_text":"- At risk for postoperative complications due to postoperative desaturation events, defined as at least one of the following circumstances: a)\tpreoperatively measured hsTnT > 25 ng/L, b)\tpreoperatively measured NT-proBNP ≥ 200 ng/L, c)\thistory of coronary artery disease, d)\thistory of peripheral artery disease (PAD), e)\t75 years of age or older, f)\thistory of transient ischemic attack (TIA) or stroke, g)\tcurrent smoking or cessation of smoking within 2 years, h)\tdiabetes (any type) or currently taking any anti-diabetic drug, i)\thyperlipidemia, j)\thistory of hypertension or currently taking any antihypertensive drug, k)\tatrial fibrillation;"}
• {"criterion_text":"- Surgery conducted under general anaesthesia AND"}
• {"criterion_text":"- Provide written informed consent."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- SpO2-TWA<90 in the first two days after surgery, measured using pulse oximetry.","definition_or_measurement_approach":"Time-weighted average (TWA) of peripheral oxygen saturation (SpO2) below 90%, measured by pulse oximetry within the first 2 days after surgery."}

Secondary endpoints

• {"endpoint_text":"- SpO2-TWA<90 in the first 24h after surgery, measured using pulse oximetry.","definition_or_measurement_approach":"Time-weighted average (TWA) of SpO2 below 90% measured by pulse oximetry within the first 24 hours after surgery."}
• {"endpoint_text":"- Score of the quality of recovery using QoR-15GE questionnaire in the evening of the first postoperative day.","definition_or_measurement_approach":"Quality of recovery assessed using the QoR-15 German version (QoR-15GE) questionnaire on the evening of postoperative day 1."}
• {"endpoint_text":"- Incidence of delirium using 3D-CAM on the first two days after surgery.","definition_or_measurement_approach":"Delirium assessed using the 3-minute Diagnostic Assessment for CAM (3D-CAM) on postoperative days 1 and 2."}
• {"endpoint_text":"- Incidence of surgical site infection documented in the hospital records and follow-up call after 30 days.","definition_or_measurement_approach":"Surgical site infection identified from hospital records and confirmed via a follow-up telephone call at 30 days."}

Austria

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

13-01-2026

Processing Time Days

496

Number Of Sites

1

Number Of Participants

210

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"Austria","full_name":"AIR LIQUIDE AUSTRIA GMBH","duties_or_roles":"Listed medicinal product (Sauerstoff medizinisch Air Liquide) for the trial (authorised product/manufacturer/supplier listed in product information)","organisation_type":""}