ANZCTR - Registration

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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]

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

ECMO

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Respiratory

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Diaphragm thickness as measured by diagnostic ultrasound

Timepoint [1]

Measured on cannulation of ECMO, and then every 48 hours until decannulation of ECMO.

Secondary outcome [1]

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]

Patients total mechanical ventilation time

Secondary outcome [2]

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]

Patients total mechanical ventilation weaning process time

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Extracorporeal Life Support Organisation

Address [1]

2800 Plymouth Rd
Building 300, Room 303
Ann Arbor, MI 48109-2800

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital, Metro North Hospital and Health Service Human Research and Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2016

Approval date [1]

18/05/2016

Ethics approval number [1]

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

Mr Trent Donnelly

Address

Physiotherapy Department
The Prince Charles Hospital, Rode Rd
Chermside, 4032
QLD

Country

Australia

Phone

+61 7 3139 4443

Fax

trent.donnelly@health.qld.gov.au

Contact person for public queries

Name

Trent Donnelly

Address

Physiotherapy Department
The Prince Charles Hospital, Rode Rd
Chermside, 4032
QLD

Country

Australia

Phone

+61 7 3139 4443

Fax

trent.donnelly@health.qld.gov.au

Contact person for scientific queries

Name

Trent Donnelly

Address

Physiotherapy Department
The Prince Charles Hospital, Rode Rd
Chermside, 4032
QLD

Country

Australia

Phone

+61 7 3139 4443

Fax

trent.donnelly@health.qld.gov.au

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.

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