Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000944437
Ethics application status
Approved
Date submitted
12/04/2016
Date registered
18/07/2016
Date last updated
18/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study investigating how Extracorporeal Membrane Oxygenation (ECMO) affects the major breathing muscles.
Scientific title
Extracorporeal Membrane Oxygenation and Development Of Diaphragm Atrophy.
Secondary ID [1] 288981 0
Nil known
Universal Trial Number (UTN)
U1111-1181-8511
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diaphragm atrophy 298376 0
ECMO 298377 0
Condition category
Condition code
Musculoskeletal 298479 298479 0 0
Other muscular and skeletal disorders
Respiratory 298480 298480 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
Ultrasound of diaphragm, to identify onset and rate of diaphragm atrophy in ECMO patients. Initial ultrasound measurements will be taken as soon as possible after initiation of ECMO therapy. Repeat ultrasound measurements will be taken every 48 hours until cessation of ECMO therapy.
Intervention code [1] 294467 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297965 0
Diaphragm thickness as measured by diagnostic ultrasound
Timepoint [1] 297965 0
Measured on cannulation of ECMO, and then every 48 hours until decannulation of ECMO.
Secondary outcome [1] 322780 0
Mechanical ventilation time. Mechanical ventilation time is assesed by extracting data from MetaVision. The Prince Charles Hospital electronic medical record system in the ICU which is linked to both the mechanical ventilator and ECMO circuits
Timepoint [1] 322780 0
Patients total mechanical ventilation time
Secondary outcome [2] 322781 0
Duration of mechanical ventilation weaning process. Mechanical ventilation time is assesed by extracting data from MetaVision. The Prince Charles Hospital electronic medical record system in the ICU which is linked to both the mechanical ventilator and ECMO circuits
Timepoint [2] 322781 0
Patients total mechanical ventilation weaning process time
Secondary outcome [3] 322782 0
Re-intubation rate. Reintubation rate will be assesed by extracting data from MetaVision. The Prince Charles Hospital electronic medical record system in the ICU which is linked to both the mechanical ventilator and ECMO circuits
Timepoint [3] 322782 0
Number of times patient re-intubated post extubation. This will be assessed via extracting data from MetaVision. The Prince Charles Hospital electronic medical record system in the ICU. This will be from the first attempt at a patients exubation to successful discharge from the ICU in that episode of care. It will not seperate ICU admissions for that patient.

Eligibility
Key inclusion criteria
All patients > 18 years old receiving ECMO therapy at The Prince Charles Hospital
Written informed consent by patient or legally authorised person.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients for whom consent was unable to be obtained
Male or female < 18 years old

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
This is a within subject design and repeated measures ANOVA will be used for statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
1/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5592 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 293337 0
Other Collaborative groups
Name [1] 293337 0
Extracorporeal Life Support Organisation
Country [1] 293337 0
United States of America
Primary sponsor type
Individual
Name
Trent Donnelly
Address
Physiotherapy Department, The Prince Charles Hospital
Rode Road
Chermside, 4032
QLD
Country
Australia
Secondary sponsor category [1] 292155 0
None
Name [1] 292155 0
Address [1] 292155 0
Country [1] 292155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294805 0
The Prince Charles Hospital, Metro North Hospital and Health Service Human Research and Ethics Committee
Ethics committee address [1] 294805 0
Ethics committee country [1] 294805 0
Australia
Date submitted for ethics approval [1] 294805 0
14/04/2016
Approval date [1] 294805 0
18/05/2016
Ethics approval number [1] 294805 0

Summary
Brief summary
The diaphragm; the major breathing muscle, as a result of life supporting mechanical ventilation reduces in size, thickness and function (Umbrello, 2016). Diaphragm atrophy and dysfunction as a result of mechanical ventilation can lead to critically ill patients having a higher intensive care unit (ICU) mortality rate, increased ICU length of stay (LOS), increased mechanical ventilation duration and a higher rate of
re-intubation (Demoule et al, 2013;). There is currently no body of evidence regarding the onset or extent of diaphragm atrophy in patients who receive Extracorporeal Membrane Oxygenation (ECMO) therapy; a patient cohort predisposed to atrophy and dysfunction of the diaphragm due to very low lung volumes delivered by the breathing machine, deep sedation and immobility.
By using diagnostic ultrasound (US) in this study, we can accurately assess diaphragm thickness and determine the onset and rate of diaphragm atrophy in the ECMO cohort
Aims:

This pilot study aims to investigate if diaphragm atrophy occurs and the rate of
diaphragm atrophy incurred whilst a patient is receiving ECMO therapy. The research
questions are:

1. Does ECMO therapy lead to diaphragm atrophy as measured by diaphragm thickness
on ultrasound?
2. What is the rate of diaphragm atrophy for patients receiving ECMO therapy?
3. Is there a difference in the rate of diaphragm atrophy between patients on VV versus
patients on VA ECMO?
Design:
As this is a pilot study, we will recruit all patients that receive ECMO therapy after consent is obtained from the patient’s next of kin. Ultrasound data and other measurements will be collected at the onset of ECMO insertion and every second day until ECMO decannulation to identify the onset and rate of diaphragm atrophy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65118 0
Mr Trent Donnelly
Address 65118 0
Physiotherapy Department
The Prince Charles Hospital, Rode Rd
Chermside, 4032
QLD
Country 65118 0
Australia
Phone 65118 0
+61 7 3139 4443
Fax 65118 0
Email 65118 0
[email protected]
Contact person for public queries
Name 65119 0
Mr Trent Donnelly
Address 65119 0
Physiotherapy Department
The Prince Charles Hospital, Rode Rd
Chermside, 4032
QLD
Country 65119 0
Australia
Phone 65119 0
+61 7 3139 4443
Fax 65119 0
Email 65119 0
[email protected]
Contact person for scientific queries
Name 65120 0
Mr Trent Donnelly
Address 65120 0
Physiotherapy Department
The Prince Charles Hospital, Rode Rd
Chermside, 4032
QLD
Country 65120 0
Australia
Phone 65120 0
+61 7 3139 4443
Fax 65120 0
Email 65120 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.