Overview

This trial is active, not recruiting.

Conditions respiratory failure, acute respiratory failure requiring intubation, pulmonary edema, pneumonia, surgical wound infection, mortality
Treatment inspiratory oxygen
Sponsor Massachusetts General Hospital
Collaborator Herlev Hospital
Start date January 2007
End date August 2014
Trial size 70000 participants
Trial identifier NCT02399878, 03-2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All non-cardiothoracic surgical patients aged 18 years or above receiving general anesthesia at Massachusetts General Hospital between January 2007 and August 2014.
inspiratory oxygen

Primary Outcomes

Measure
Postoperative respiratory complications
time frame: 7 days after surgery

Secondary Outcomes

Measure
Postoperative reintubation
time frame: 7 days after surgery
Postoperative respiratory failure
time frame: 7 days after surgery
Postoperative pneumonia
time frame: 7 days after surgery
Postoperative pulmonary edema
time frame: 7 days after surgery
Postoperative surgical site infection
time frame: 21 days after surgery
Postoperative admission to the intensive care unit
time frame: 7 days after surgery
Postoperative mortality
time frame: 7 days after surgery
Postoperative mortality
time frame: 30 days after surgery
Postoperative length of stay
time frame: 360 days after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications
Principal investigator Matthias Eikermann, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.