Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

• Conditions: Respiratory Failure; Mortality; Acute Respiratory Failure Requiring Intubation; Pulmonary Edema; Pneumonia; Surgical Wound Infection
• Interventions: Drug: Inspiratory oxygen

• Registration Number: NCT02399878
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Respiratory complications represent the second most frequent type of postoperative complications with an incidence estimated to range from 2.0% to 7.9%

It has been shown that intra-operative protective ventilation is associated with a reduced risk of respiratory complications. The effects of intra-operative inspiratory oxygen fraction (FiO2) remain to be investigated.

In this study, the investigators aim to investigate the association between intra-operative FiO2 and respiratory complication as well as surgical site infection and ICU admission in patients undergoing non-cardiothoracic surgery. The investigators primary hypothesis is that high intra-operative FiO2 increases the risk of postoperative respiratory complications independent of predefined risk factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2014-08
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70000

Inclusion Criteria

• Non-cardiothoracic surgery at Massachusetts General Hospital between January 2007 and August 2015
• Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure
• above18 years of age

Exclusion Criteria

• Missing information regarding main characteristics or the exposure variable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing surgery	Inspiratory oxygen	All non-cardiothoracic surgical patients aged 18 years or above receiving general anesthesia at Massachusetts General Hospital between January 2007 and August 2014.

Primary Outcome Measures

Name	Time	Method
Postoperative respiratory complications	7 days after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative pulmonary edema	7 days after surgery
Postoperative surgical site infection	21 days after surgery
Postoperative mortality	30 days after surgery
Postoperative pneumonia	7 days after surgery
Postoperative admission to the intensive care unit	7 days after surgery
Postoperative respiratory failure	7 days after surgery
Postoperative length of stay	360 days after surgery
Postoperative reintubation	7 days after surgery