Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

March 29, 2016 updated by: Matthias Eikermann, Massachusetts General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

70000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative respiratory complications
Time Frame: 7 days after surgery
7 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Rigshospitalet, Denmark
Herlev Hospital

Investigators

  • Principal Investigator: Matthias Eikermann, MD, PhD, MGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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