Intra-operative Inspiratory Oxygen Fraction and Postopera... | NCT02399878

Studies
Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

NCT02399878

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Mar 31, 2016Estimated

Enrollment

70,000Estimated

Phase

Not provided

Conditions

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

Interventions

Inspiratory oxygen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Aug 2014Actual

Completion Date

Not provided

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Eikermann, MD, PhD, Associate Professor, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Herlev Hospital	OTHER
Rigshospitalet, Denmark	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Inspiratory oxygen	Drug		Patients undergoing surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative respiratory complications		7 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Postoperative reintubation		7 days after surgery
Postoperative respiratory failure		7 days after surgery
Postoperative pneumonia

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Matthias Eikermann, MD, PhD	MGH	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28974067	Derived	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.

ID	Term
D012131	Respiratory Insufficiency
D011654	Pulmonary Edema
D011014	Pneumonia
D013530	Surgical Wound Infection

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D008171	Lung Diseases
D012141	Respiratory Tract Infections