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Pilot study investigating how Extracorporeal Membrane Oxygenation (ECMO) affects the major breathing muscles.

Extracorporeal Membrane Oxygenation and Development Of Diaphragm Atrophy.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000944437
Enrollment
20
Registered
2016-07-18
Start date
2016-08-01
Completion date
2017-08-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Trent Donnelly
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients > 18 years old receiving ECMO therapy at The Prince Charles Hospital Written informed consent by patient or legally authorised person.

Exclusion criteria

Patients for whom consent was unable to be obtained Male or female < 18 years old

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026