Respiratory FailureNCT00854165
Lung Transplantation in Respiratory Failure Patients
An observational study of Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Failure
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Jun 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between July 2006 and July 2008, we performed bilateral sequential lung transplantation under venoarterious ECMO support in 10 respiratory failure patients with various lung diseases. This study wanted to report the preoperative condition, postoperative complications, and short-term outcome after lung transplantation.
Who may be able to join
- respiratory patients depended on ventilator supports prior to lung transplant
Who cannot join
- non-cardaveric lung transplant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Surgery, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Extracorporeal Membrane Oxygenation Support for Bilateral Sequential Lung Transplantation in Respiratory Failure Patients.
Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. The objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .
Read the detailed description
The one-year survival rate and postoperative pulmonary functional results will be reported in this study.
- Conditions
- Respiratory Failure
- Keywords
- lung transplantation, respiratory failure, ECMO, Lung transplants in respiratory failure patients
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months and one year survival after lung transplatn.
Measured: 6 months and one year posttransplant
Secondary outcomes (1)
Pulmonary function results, at baseline and posttransplant 1, 3, and 6 months.
Measured: baseline, post-op 1,3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yung-Chie Lee, MD, PhD, Study director, Department of Surgery, National Taiwan University HospitalHsao-Hsun Hsu, MD, Principal investigator, Department of Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854165
- Sponsor's protocol ID
- 200901015R
- Status last verified
- Mar 2009
- First submitted
- 1 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation Support for Bilateral Sequential Lung Transplantation in Respiratory Failure Patients.
- ClinicalTrials.gov ID
- NCT00854165
- Acronym / sponsor ID
- 200901015R
- Conditions
- Respiratory Failure
- Keywords
- lung transplantation, respiratory failure, ECMO, Lung transplants in respiratory failure patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 3 Mar 2009 (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.
Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. The objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .
Detailed description
The one-year survival rate and postoperative pulmonary functional results will be reported in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between July 2006 and July 2008, we performed bilateral sequential lung transplantation under venoarterious ECMO support in 10 respiratory failure patients with various lung diseases. This study wanted to report the preoperative condition, postoperative complications, and short-term outcome after lung transplantation.
Key inclusion criteria (1 listed)
- respiratory patients depended on ventilator supports prior to lung transplant
Key exclusion criteria (1 listed)
- non-cardaveric lung transplant
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
6 months and one year survival after lung transplatn.
Time frame: 6 months and one year posttransplant
1 secondary outcome
Pulmonary function results, at baseline and posttransplant 1, 3, and 6 months.
Time frame: baseline, post-op 1,3, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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Mechanical Ventilator Adjustments and Patient Dyspnea
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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.
Yung-Chie Lee, MD, PhD study director
Department of Surgery, National Taiwan University Hospital
Hsao-Hsun Hsu, MD principal investigator
Department of Surgery, National Taiwan University Hospital
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 Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2009. 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 Taiwan. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
6 months and one year survival after lung transplatn. (time frame: 6 months and one year posttransplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2009.