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Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02399878
Enrollment
70000
Registered
2015-03-26
Start date
2007-01-31
Completion date
Unknown
Last updated
2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure Requiring Intubation, Mortality, Pneumonia, Pulmonary Edema, Respiratory Failure, Surgical Wound Infection

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.

Interventions

DRUGInspiratory oxygen

Sponsors

Herlev Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative respiratory complications7 days after surgery

Secondary

MeasureTime frame
Postoperative reintubation7 days after surgery
Postoperative respiratory failure7 days after surgery
Postoperative pulmonary edema7 days after surgery
Postoperative pneumonia7 days after surgery
Postoperative admission to the intensive care unit7 days after surgery
Postoperative mortality7 days after surgery
Postoperative length of stay360 days after surgery
Postoperative surgical site infection21 days after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026