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NCT02399878 Clinical Trial

Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

Pneumonia Clinical Trial

Official title:
Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02399878
Other study ID # 03-2015
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 23, 2015
Last updated March 25, 2015
Start date January 2007

Study information
Verified date March 2015
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70000
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Inspiratory oxygen

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Massachusetts General Hospital Herlev Hospital, Rigshospitalet, Denmark

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative respiratory complications 7 days after surgery Yes
Secondary Postoperative reintubation 7 days after surgery Yes
Secondary Postoperative respiratory failure 7 days after surgery Yes
Secondary Postoperative pneumonia 7 days after surgery Yes
Secondary Postoperative pulmonary edema 7 days after surgery Yes
Secondary Postoperative surgical site infection 21 days after surgery Yes
Secondary Postoperative admission to the intensive care unit 7 days after surgery Yes
Secondary Postoperative mortality 7 days after surgery Yes
Secondary Postoperative mortality 30 days after surgery Yes
Secondary Postoperative length of stay 360 days after surgery Yes
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