Respiratory FailureNCT02399878
Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications
An observational study of Respiratory Failure and Acute Respiratory Failure Requiring Intubation, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Acute Respiratory Failure Requiring Intubation, Pulmonary Edema
- What is being tested?
- Inspiratory oxygen
- How many people
- 70,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Missing information regarding main characteristics or the exposure variable
About this study
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
- Being tested
- Inspiratory oxygen
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Edema, Pneumonia, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory oxygenDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Inspiratory oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative respiratory complications
Measured: 7 days after surgery
Secondary outcomes (9)
Postoperative reintubation
Measured: 7 days after surgery
Postoperative respiratory failure
Measured: 7 days after surgery
Postoperative pneumonia
Measured: 7 days after surgery
Postoperative pulmonary edema
Measured: 7 days after surgery
Postoperative surgical site infection
Measured: 21 days after surgery
Postoperative admission to the intensive care unit
Measured: 7 days after surgery
Postoperative mortality
Measured: 7 days after surgery
Postoperative mortality
Measured: 30 days after surgery
Postoperative length of stay
Measured: 360 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJan 2007
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
- Investigators
- Matthias Eikermann, MD, PhD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399878
- Sponsor's protocol ID
- 03-2015
- Status last verified
- Mar 2016
- First submitted
- 23 Mar 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
Publications
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.
PubMed 28974067
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications
- ClinicalTrials.gov ID
- NCT02399878
- Acronym / sponsor ID
- 03-2015
- Conditions
- Respiratory Failure, Acute Respiratory Failure Requiring Intubation, Pulmonary Edema, Pneumonia, Surgical Wound Infection, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2007
- Primary completion
- Aug 2014 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery | – | Drug: Inspiratory oxygenAll non-cardiothoracic surgical patients aged 18 years or above receiving general anesthesia at Massachusetts General Hospital between January 2007 and August 2014. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Missing information regarding main characteristics or the exposure variable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory oxygen | Drug | Patients undergoing surgery |
Primary outcome
Postoperative respiratory complications
Time frame: 7 days after surgery
9 secondary outcomes
Postoperative reintubation
Time frame: 7 days after surgery
Postoperative respiratory failure
Time frame: 7 days after surgery
Postoperative pneumonia
Time frame: 7 days after surgery
Postoperative pulmonary edema
Time frame: 7 days after surgery
Postoperative surgical site infection
Time frame: 21 days after surgery
Postoperative admission to the intensive care unit
Time frame: 7 days after surgery
Postoperative mortality
Time frame: 7 days after surgery
Postoperative mortality
Time frame: 30 days after surgery
Postoperative length of stay
Time frame: 360 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 28974067Staehr-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Eikermann, MD, PhD principal investigator
MGH
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Acute Respiratory Failure Requiring Intubation, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative respiratory complications (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.