Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000530426
Ethics application status
Approved
Date submitted
13/02/2016
Date registered
22/04/2016
Date last updated
27/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasonography of respiratory muscles to estimate the probability of extubation failure after cardiothoracic surgery
Scientific title
Can extubation failure after cardiothoracic surgery be predicted by echography of the diaphragm muscles?
Secondary ID [1] 288531 0
None
Universal Trial Number (UTN)
U1111-1180-1999
Trial acronym
EXPEDIA Study: EXtubation failure Prediction by Echography of the DIAphragm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute respiratory failure 297627 0
Condition category
Condition code
Respiratory 297812 297812 0 0
Other respiratory disorders / diseases
Surgery 297813 297813 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Days
Description of intervention(s) / exposure
Occurrence of acute respiratory failure during weaning process defined as:
- Failure of a spontaneous breathing trial
- Post extubation acute respiratory failure
Duration of observation will be 2 days if extubation occurs
Diaphragm thickness (tdi) will be measured in the zone of apposition of the diaphragm to the rib cage using a 10-MHz linear ultrasound probe. Diaphragm thickening fraction (TFdi) will be defined as the percentage change in tdi between end-expiration and end-inspiration. Those index will be calculated in each patients during ventilation with pressure support (PS) and during SBT on the right and left sides. Ultrasound performed 10 minutes after beginning of PS and 10 minutes after beginning of SBTWeaning failures will be defined by reintubation within 48 hours post extubation or failure of the SBT.
Intervention code [1] 293905 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297338 0
Diaphragm thickening fraction using a 10-MHz linear ultrasound probe.
Timepoint [1] 297338 0
At the end of a spontaneous breathing trial
Primary outcome [2] 297339 0
Extubation failure defined as
failure of a spontaneous breathing trial or a respiratory failure occuring during the next 48 hours following extubation
Timepoint [2] 297339 0
end of a spontaneous breathing trial and during the 48 hours after extubation.
Secondary outcome [1] 320760 0
Change in diaphragm thickening fraction between breathing during pressure support and SBT, assessed by 10-MHz linear ultrasound probe
Timepoint [1] 320760 0
end of the pressure support
end of the spontaneous breathing trial

Eligibility
Key inclusion criteria
Adult patients after cardiothoracic surgery under mechanical ventilation and eligible to weaning process according to the attending physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diaphragmatic palsy
pregnant women
patient's refusal
infants and youngs

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Normality of data distribution will be assessed using the Kolmogorov-Smirnov test. Continuous variables will be described as mean (SD) or median [interquartile range (IQR)] and compared using Student's t test or the Mann-Whitney U test, as appropriate. The chi-square test or Fisher’s exact test are chosen to compare categorical variables. Sensitivity (Se), specificity (Sp), and predictive values were computed using standard formulas. A P value <0.05 was considered significant.
After a preliminary study, we evaluated that a 30% increase of diaphragm thickening fraction led to a sensitivity of 100% and a specificity of 84% for extubation failure. Therefore, for a sensitivity with a 95%-condidence interval=90%-100%, we need to evaluate 5 patients with extubation failure. For a specificity with a 95%-condidence interval=77%-97%, we need to evaluate 43 patients with extubation success.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
28/10/2016
Actual
25/11/2016
Date of last data collection
Anticipated
Actual
27/11/2016
Sample size
Target
48
Accrual to date
Final
53
Recruitment outside Australia
Country [1] 7588 0
France
State/province [1] 7588 0

Funding & Sponsors
Funding source category [1] 292878 0
Hospital
Name [1] 292878 0
Hopital Marie Lannelongue
Country [1] 292878 0
France
Primary sponsor type
Hospital
Name
Hopital Marie Lannelongue
Address
133 avenue de la Resistance 92350 Le Plessis robinson
Country
France
Secondary sponsor category [1] 291621 0
None
Name [1] 291621 0
None
Address [1] 291621 0
None
Country [1] 291621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294382 0
Comite de Protection des Personnes Ile de France VII
Ethics committee address [1] 294382 0
Hopital de Bicetre
78 rue du General Leclerc
94275 Le Kremlin
Ethics committee country [1] 294382 0
France
Date submitted for ethics approval [1] 294382 0
06/11/2013
Approval date [1] 294382 0
11/12/2013
Ethics approval number [1] 294382 0
2013-A01552

Summary
Brief summary
The failure of weaning from mechanical ventilation can be associated with a diaphragmatic dysfunction after thoracic cardiovascular surgery. Ultrasound measurements of diaphragm tickening may be useful to monitor diaphragm activity of each half diaphragm. We expect to establish a sonographic criteria during the spontaneous breathing trial (SBT) to predict weaning failure from mechanical ventilation after cardio thoracic surgery. Patients after majors cardio or thoracic surgery who met criteria for a spontaneous breathing trial will be enrolled. All patients with a half diaphragm paralyzed will be excluded. Diaphragm thickness (tdi) will be measured in the zone of apposition of the diaphragm to the rib cage using a 10-MHz linear ultrasound probe. Diaphragm thickening fraction (TFdi) will be defined as the percentage change in tdi between end-expiration and end-inspiration. Those index will be calculated in each patients during ventilation with pressure support (PS) and during SBT on the right and left sides. Weaning failures will be defined by reintubation within 48 hours post extubation or failure of the SBT.
We have planne to enrolled prospectively 48 patients. We will evaluate the sensitivity and specificity of diaphragm thickening fraction to predict SBT or extubation failure. The area under the receiver operating characteristic curve will be calculated. We expected to show that ultrasound measures of diaphragm thickening may be useful to predict extubation success or failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63518 0
Prof STEPHAN Francois
Address 63518 0
Reanimation adulte
Hopital Marie Lannelongue
133 avenue de la Resistance
92350 Le Plessis Robinson
Country 63518 0
France
Phone 63518 0
+33 1 40 94 85 80
Fax 63518 0
+ 33 1 40 94 85 86
Email 63518 0
[email protected]
Contact person for public queries
Name 63519 0
Prof STEPHAN Francois
Address 63519 0
Reanimation adulte
Hopital Marie Lannelongue
133 avenue de la Resistance
92350 Le Plessis Robinson
Country 63519 0
France
Phone 63519 0
+33 1 40 94 85 80
Fax 63519 0
+33 1 40 94 85 86
Email 63519 0
[email protected]
Contact person for scientific queries
Name 63520 0
Prof STEPHAN Francois
Address 63520 0
Reanimation adulte
Hopital Marie Lannelongue
133 avenue de la Resistance
92350 Le Plessis Robinson
Country 63520 0
France
Phone 63520 0
+33 1 40 94 85 80
Fax 63520 0
+33 1 40 94 85 86
Email 63520 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.