Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000596404
Ethics application status
Approved
Date submitted
4/05/2016
Date registered
9/05/2016
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of ultrasound to determine changes in diaphragm mechanics during a spontaneous breathing trial
Scientific title
Use of ultrasound to determine changes in diaphragm mechanics during a spontaneous breathing trial
Secondary ID [1] 289125 0
Nil known
Universal Trial Number (UTN)
U1111-1182-4973
Trial acronym
DUET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weaning from mechanical ventilation 298602 0
Respiratory failure 298603 0
Diaphragmatic dysfunction 298604 0
Condition category
Condition code
Respiratory 298674 298674 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Weaning from mechanical ventilation is one of the most common activities undertaken in intensive care. Currently, the gold standard for weaning and assessing for extubation is a spontaneous breathing trial (SBT). Diaphragmatic ultrasound is an emerging tools that may have considerable utility in augmenting the decision making process surrounding weaning and extubation. We aim to assess diaphragmatic function via ultrasound and electromyographic activity analysis at the start and end of a spontaneous breathing trial.

A spontaneous breathing trial consists of the patient being placed on a T-piece without PEEP and given enough supplemental oxygen to maintain adequate oxygen saturation. For a spontaneous breathing trial to be considered successful, it must last at least 30 minutes.

Patients who are planned to undergo a spontaneous breathing trial as part of their usual care will be considered for the trial.

Ultrasound assessment of the right hemidiaphragm will be conducted within the first 5 minutes of the SBT and at 30 minutes. This will be conducted by a qualified ultrasonographer with the patient lying at 45 degrees. Measurement of diaphragmatic excursion, speed of diaphragmatic contraction and diaphragmatic thickness (at end-inspiration and end-expiration) will be conducted at both assessments.
Intervention code [1] 294631 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298165 0
Diaphragmatic activity over the course of a spontaneous breathing trial measured by ultrasound
Ultrasound derived parameters
* Diaphragm thickness at end inspiration and end expiration
* Diaphragmatic thickening fraction- (Thickness at end inspiration - Thickness at end expiration) / Thickness at end expiration
* Diaphragmatic excursion (DE) - displacement measured in cm
* Diaphragmatic contraction speed measured in cm/s
Timepoint [1] 298165 0
Measured at 5 minutes and 30 minutes during SBT
In the event of SBT failure, prior to recommencement of mechanical ventilation if safe
Primary outcome [2] 298166 0
Outcome of SBT (success / failure)

Success determined by remaining on T-piece for >30 minutes
Failure determined by need to return to mechanical ventilation <30 miutes due to RR > 38 (or >50% increase from baseline), HR >140 (or >25% increase from baseline), SBP 40mmHg above baseline or anxiety/agitation, cardiac arrhythmias or respiratory acidosis
Timepoint [2] 298166 0
Recorded at conclusion of SBT
Secondary outcome [1] 323346 0
Extubation success or failure

Determined by review of clinical records
Success if patient remains extubated at 48 hours
Failure if patient required re-intubation or passes away secondary to recurrent respiratory failure (in a patient deemed not for re-intubation)
Timepoint [1] 323346 0
48 hours post SBT

Eligibility
Key inclusion criteria
* Patient intubated and mechanically ventilated for at least 24 hours over the age of 18
* Planned to undergo spontaneous breathing trial as per unit protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Neuromuscular disease likely to result in diaphragmatic dysfunction
* Inability to visualise diaphragm on ultrasound
* Inability to access right chest wall due to dressings or surgical site
* Inability to sit at 45 degrees
* Diaphragmatic injury as a result of trauma or surgery
* Pregnancy
* Unilateral diaphragmatic or phrenic nerve pathology
* Patients whom life support would be withheld, withdrawn, or who are not expected to survive their ICU admission

Specific to Edi patients
* Nasogastric catheter placement contra-indicated
* Inability to place Edicatheter
* Edi capable ventilator not available

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We propose to recruit 100 participants to the study. This is based on what can be feasibly obtained over a 1-year recruitment period as well as having sufficient numbers to conduct our proposed analyses. With 100 participants we expect 25-35 will fail the SBT. Of the successes we expect around 20% will fail extubation due to recurrent respiratory failure. This equates to approximately 15 participants expected to fail extubation.

Patients will be split into two groups; those that are deemed to fail SBT and those that pass. Ultrasound derived diaphragmatic parameters as well as population and other measures will undergo between group comparison using Wilcoxon 2-sample test for continuous measures and Fishers exact test for categorical measures. Clinical significance of differences between the 2 groups will also be considered. All variables showing clinically or statistically significant differences between groups will be further considered for inclusion in a prediction model for successful completion of SBT using logistic regression. Due to the potential for overfitting a prediction model with limited expected numbers of “events” we will use forward selection for model building.

Patients who successfully complete SBT will also be split into 2 groups based on success or failure of extubation. A similar analytical procedure as described in the previous paragraph will be used to compare the 2 groups although it is unlikely there will be sufficient failures for prediction modelling.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
16/05/2016
Actual
17/08/2016
Date of last participant enrolment
Anticipated
Actual
24/01/2018
Date of last data collection
Anticipated
Actual
4/02/2018
Sample size
Target
100
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5715 0
Logan Hospital - Meadowbrook

Funding & Sponsors
Funding source category [1] 293494 0
Hospital
Name [1] 293494 0
Logan Hospital Intensive Care Unit
Country [1] 293494 0
Australia
Primary sponsor type
Individual
Name
Dr Hayden White
Address
Intensive Care Unit
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
Queensland, Australia
Country
Australia
Secondary sponsor category [1] 292321 0
None
Name [1] 292321 0
None
Address [1] 292321 0
None
Country [1] 292321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294951 0
Metro South Human Research Ethics Committee (EC00167)
Ethics committee address [1] 294951 0
Ethics committee country [1] 294951 0
Australia
Date submitted for ethics approval [1] 294951 0
15/03/2016
Approval date [1] 294951 0
19/04/2016
Ethics approval number [1] 294951 0
HREC/16/QPAH/212

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65450 0
Dr Hayden White
Address 65450 0
Logan Hospital
Armstrong Rd
Meadowbrook
QLD 4131
Country 65450 0
Australia
Phone 65450 0
+61732998899
Fax 65450 0
Email 65450 0
[email protected]
Contact person for public queries
Name 65451 0
Hayden White
Address 65451 0
Logan Hospital
Armstrong Rd
Meadowbrook
QLD 4131
Country 65451 0
Australia
Phone 65451 0
+61732998899
Fax 65451 0
Email 65451 0
[email protected]
Contact person for scientific queries
Name 65452 0
Hayden White
Address 65452 0
Logan Hospital
Armstrong Rd
Meadowbrook
QLD 4131
Country 65452 0
Australia
Phone 65452 0
+61732998899
Fax 65452 0
Email 65452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not built intro trial design


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.