Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

NCT02399878 | Unknown

• 1 other identifier: 03-2015
• Study Type: observational
• Target: 70,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative respiratory complications

  7 days after surgery

Secondary Outcomes (9)

• Postoperative reintubation

  7 days after surgery

• Postoperative respiratory failure

  7 days after surgery

• Postoperative pneumonia

  7 days after surgery

• Postoperative pulmonary edema

  7 days after surgery

• Postoperative surgical site infection

  21 days after surgery

Study Arms (1)

Patients undergoing surgery

All non-cardiothoracic surgical patients aged 18 years or above receiving general anesthesia at Massachusetts General Hospital between January 2007 and August 2014.

Drug: Inspiratory oxygen

Interventions

Inspiratory oxygen DRUG

Patients undergoing surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Missing information regarding main characteristics or the exposure variable

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Related Publications (1)

• 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.

  PMID: 28974067 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Edema; Pneumonia; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Infections; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Eikermann, MD, PhD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: January 1, 2007
• Primary Completion: August 1, 2014
• Last Updated: March 31, 2016

Record last verified: 2016-03