Respiratory Distress Syndrome, AdultNCT00157144
Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005
An observational study of Respiratory Distress Syndrome, Adult and Respiratory Insufficiency, run by Bayside Health at 1 site in Australia.
Trial summary
Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function of the human lung and/or heart outside the body. Its use is escalating in a wide range of clinical settings in the adult population without evidence or guidelines to support this practice. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Respiratory Insufficiency, Shock, Cardiogenic
- How many people
- Not given
- Where
- 1 siteAustralia
- Study dates
- Oct 2004to Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving ECMO in Australia and New Zealand
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function of the human lung and/or heart outside the body. Its use is escalating in a wide range of clinical settings in the adult population without evidence or guidelines to support this practice.
This study involves a nationwide questionnaire which has two components. The initial pilot survey will attempt to identify all institutions currently practicing ECMO or those intending to do so in the future, and are willing to participate in prospective data collection. The second phase will involve a monthly survey of these centres regarding the extent of ECMO use, practice details implemented, and outcome data.
It is hoped that the collection of this information will later assist in the development of guidelines for this expensive and presently unsubstantiated practice, together with the construction of appropriate training programs for staff.
- Keywords
- Lung Transplantation, Heart Transplantation
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Shock, Cardiogenic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vincent A Pellegrino, MBBS, Principal investigator, National Health and Medical Research Council, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157144
- Sponsor's protocol ID
- 186/04
- Status last verified
- Mar 2014
- First submitted
- 9 Sep 2005
- Last updated
- 10 Mar 2014
- Results posted
- No
Publications
Hastings SL, Pellegrino VA, Preovolos A, Salamonsen RF. Survey of adult extracorporeal membrane oxygenation (ECMO) practice and attitudes among Australian and New Zealand intensivists. Crit Care Resusc. 2008 Mar;10(1):46.
PubMed 18304017
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005
- ClinicalTrials.gov ID
- NCT00157144
- Acronym / sponsor ID
- 186/04
- Keywords
- Lung Transplantation, Heart Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Bayside HealthOther government
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function of the human lung and/or heart outside the body. Its use is escalating in a wide range of clinical settings in the adult population without evidence or guidelines to support this practice.
This study involves a nationwide questionnaire which has two components. The initial pilot survey will attempt to identify all institutions currently practicing ECMO or those intending to do so in the future, and are willing to participate in prospective data collection. The second phase will involve a monthly survey of these centres regarding the extent of ECMO use, practice details implemented, and outcome data.
It is hoped that the collection of this information will later assist in the development of guidelines for this expensive and presently unsubstantiated practice, together with the construction of appropriate training programs for staff.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving ECMO in Australia and New Zealand
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
- Derived from this study: PubMed 18304017Hastings SL, Pellegrino VA, Preovolos A, Salamonsen RF. Survey of adult extracorporeal membrane oxygenation (ECMO) practice and attitudes among Australian and New Zealand intensivists. Crit Care Resusc. 2008 Mar;10(1):46.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent A Pellegrino, MBBS principal investigator
National Health and Medical Research Council, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Respiratory Insufficiency, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00157144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.