Effect of Supplemental Oxygen on Heart Function Blood Parameters

Phase 1

• Conditions: Evaluation of the effect of 80% versus 30% supplemental oxygen administration during major abdominal surgery on postoperative brain natriuretic peptide concentration.; MedDRA version: 20.0Level: PTClassification code 10059883Term: Fraction of inspired oxygenSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10050322Term: Oxygen supplementationSystem Organ Class: 100000173317; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003714-68-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-06
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery:
1.History of coronary artery disease
2.History of peripheral arterial disease
3.History of stroke OR
4.Any of 3 of 7
A)Age = 70 years
B)Undergoing major surgery
C)History of congestive heart failure
D)History of transient ischemic attack
E)Diabetes and currently taking an oral hypoglycemic agent or insulin
F)History of Hypertension

Further inclusion criteria are:
1.Written informed consent
2.Elective major abdominal open surgery or laparoscopically assisted procedures scheduled to take over two hours done under general anesthesia (colorectal, urology, gynecology, liver and pancreatic surgery)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Symptoms of infection or sepsis
2.Preoperative inotropic therapy
3.Patients under ICU treatment
4.Oxygen dependent patients
5. History of severe heart failure and/or EF < 30%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified