Reduction of surgical wound infection breathing high concentrations of oxygen during anesthesia

Phase 1

• Conditions: The study population will be patients who are scheduled for major abdominal (laparotomy and laparoscopic) surgery under general anaesthesia.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-002936-34-ES
• Lead Sponsor: Francisco Javier Belda Nacher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 756

Inclusion Criteria

1) Male or female patients =18 years old,
2) Body mass index (BMI) of <35 kg/m2
3) Scheduled for major abdominal (laparotomy and laparoscopic) surgery with an expected surgery duration of more than 2h.
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 456
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1) < 18 years
2) Pregnant woman or in breast-feeding status
3) Body mass index (BMI) > 35 Kg/m2
4) Moderate or severe acute respiratory distress syndrome (ARDS; PaO2/ FIO2 < 200 mmHg)
5) Diagnosis of heart failure defined as a cardiac index < 2.5 ml/min/m2 or > 2.5 when = 5µg/kg/min dobutamine is required, or suspected heart failure according to clinical signs (hypotension, oliguria, pulmonary edema) together with NT-proBNP > 13pg/ml,
6) Suspected intracranial hypertension (> 15 mmHg)
7) Presence of pneumothorax or giant bullae on a chest radiograph or computed tomography (CT)
8) Patients participating in another interventional study.

Study & Design

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