Clinical trial NCT02399878: Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications
Official title: Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Acute Respiratory Failure Requiring Intubation
Pulmonary Edema
Pneumonia
Surgical Wound Infection
Mortality
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Rigshospitalet, Denmark
First posted: 2015-03-26
Enrollment: 70000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All non-cardiothoracic surgical patients aged 18 years or above receiving general anesthesia at Massachusetts General Hospital between January 2007 and August 2014

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative respiratory complications
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Postoperative reintubation
timeFrame: 7 days after surgery
measure: Postoperative respiratory failure
timeFrame: 7 days after surgery
measure: Postoperative pneumonia
timeFrame: 7 days after surgery
measure: Postoperative pulmonary edema
timeFrame: 7 days after surgery
measure: Postoperative surgical site infection
timeFrame: 21 days after surgery
measure: Postoperative admission to the intensive care unit
timeFrame: 7 days after surgery
measure: Postoperative mortality
timeFrame: 7 days after surgery
measure: Postoperative mortality
timeFrame: 30 days after surgery
measure: Postoperative length of stay
timeFrame: 360 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: MGH
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staehr-Rye AK, Meyhoff CS, Scheffenbichler FT, Vidal Melo MF, Gatke MR, Walsh JL, Ladha KS, Grabitz SD, Nikolov MI, Kurth T, Rasmussen LS, Eikermann M. High intraoperative inspiratory oxygen fraction and risk of major respiratory complications. Br J Anaesth. 2017 Jul 1;119(1):140-149. doi: 10.1093/bja/aex128.