Cardiac Surgery and Diaphragm Function
September 22, 2015 updated by: University Hospital, Grenoble
Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress.
The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation.
The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grenoble, France, 38043
- Unité de Réanimation Cardio-vasculaire et Thoracique
-
-
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
Non-Probability Sample
Study Population
patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery
Description
Inclusion Criteria:
- 18 years old and older
- planned surgery
- ready for weaning from mechanical ventilation
Exclusion Criteria:
- protected patient
- patient refusal
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diaphragm inspiratory thickening fraction
Time Frame: At the begining of the spontaneous breathing trial (around 4hours after surgery)
|
At the begining of the spontaneous breathing trial (around 4hours after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diaphragm dysfunction before surgery
Time Frame: the day before surgery
|
the day before surgery
|
|
Severity score (Euroscore)
Time Frame: the day before surgery
|
the day before surgery
|
|
extracorporeal circulation duration
Time Frame: peroperative
|
peroperative
|
|
left ventricular ejection fraction
Time Frame: the day before surgery
|
the day before surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
- McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available. Erratum In: N Engl J Med. 2012 May 31;366(22):2138.
- Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
- Moury PH, Cuisinier A, Durand M, Bosson JL, Chavanon O, Payen JF, Jaber S, Albaladejo P. Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study. Ann Intensive Care. 2019 Apr 24;9(1):50. doi: 10.1186/s13613-019-0521-z.
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
June 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
August 1, 2014
First Submitted That Met QC Criteria
August 4, 2014
First Posted (Estimate)
August 5, 2014
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014-13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.