High oxygen administration and cardiac complications in colorectal surgery

Cardiac complications associated to perioperative hyperoxia in elective colorectal surgery - TropoO2

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001917-34-ES

Enrollment

400

Registered

2018-11-05

Start date

2018-12-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular complications after colorectal surgery MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10050322 Term: Oxygen supplementation System Organ Class: 100000004865

Interventions

Trade Name: Oxigeno Medicinal Liquido Carburos Metálicos, gas para inhalación, 99'5% V/V Product Name: OXÍGENO MEDICINAL Product Code: 67503 Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Elective colorectal surgery - Age > 18 year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - Pregnancy - severe COPD - Acute cardiovascular syndrom 6 weeks prior surgery - Hemodialysis - General anesthesia administered 1 month prior surgery - The impossibility to sign / to understand the informed consent - Intraoperative complications that requires mechanical ventilation or vasoactive drugs in the postoperative period

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to assess if hyperoxia ( intraoperative FiO2 >80%) increases the postoperative incidence of myocardic injury during first 96 hours after surgery; Secondary Objective: - Cardiovascular complications at 30 days postoperative - Mortality at 30 days postoperative - Cardiovascular complications at 1 year postoperative - Mortality at 1 year postoperative ; Primary end point(s): Myocardial injury, described as: - MINS (myocardial injury after non cardiac surgery) - Acute coronary syndrom ( including acute myocardial infarction, unstable angina and sudden cardiac death) ;Timepoint(s) of evaluation of this end point: 96 hours postoperative	—

Measure

Time frame

Main Objective: The main objective is to assess if hyperoxia ( intraoperative FiO2 >80%) increases the postoperative incidence of myocardic injury during first 96 hours after surgery; Secondary Objective: - Cardiovascular complications at 30 days postoperative - Mortality at 30 days postoperative - Cardiovascular complications at 1 year postoperative - Mortality at 1 year postoperative ; Primary end point(s): Myocardial injury, described as: - MINS (myocardial injury after non cardiac surgery) - Acute coronary syndrom ( including acute myocardial infarction, unstable angina and sudden cardiac death) ;Timepoint(s) of evaluation of this end point: 96 hours postoperative

—

Secondary

Measure	Time frame
Secondary end point(s): - New diagnosis of cardiovascular diseases : arrhythmias of new appearance, heart failure, invasive coronary procedure, pulmonary thromboembolism, stroke - Death ;Timepoint(s) of evaluation of this end point: 30 days and 1 year postoperative	—

Countries

Spain

Contacts

Public ContactServicio de Anestesiología

Consorci Mar Parc de Salut de Barcelona

60770@parcdesalutmar.cat0034932483350

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026