免费获得国外相关药品，最快 1 个工作日回馈药物信息
Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study. (NHS ECMO)
This is an observational study of outcomes of the NHS England-commissioned national respiratory ECMO service, which has been active at six centres since December 2011.
The primary outcome of interest is the number of patients who survive to ICU discharge at the ECMO centre. The study also aims to identify factors predictive of outcome.
| Condition or disease | Intervention/treatment |
|---|---|
| Acute Respiratory Failure | Device: Extracorporeal Membrane Oxygenation |
Recent randomised and observational studies suggest there may be a role for extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory failure that have not responded to conventional measures.
In 2011, NHS England commissioned a national service to provide ECMO for severe respiratory failure at six centres across the country. Patients with severe respiratory failure are referred to the network if conventional measures are unsuccessful, and if accepted are transferred to an ECMO centre for specialist care. The criteria for admission is at the discretion of clinicians at each centre.
The NHS ECMO registry has been created by cross-referencing data submitted to the Extracorporeal Life Support Organisation (ELSO) in Ann Arbor, Michigan, with a tracker document identifying patients treated within the network. Analysis has been undertaken from December 2018 to March 2019.
| Study Type : | Observational |
| Actual Enrollment : | 1205 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study. |
| Actual Study Start Date : | December 1, 2011 |
| Actual Primary Completion Date : | March 31, 2018 |
| Actual Study Completion Date : | March 31, 2018 |
- Survival at ECMO ICU discharge [ Time Frame: Up to 90 days. ]The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.
- Duration of ECMO treatment. [ Time Frame: Up to 90 days. ]The time (hours) where the patient is actively supported by the ECMO circuit.
- Frequency of Complications [ Time Frame: Up to 90 days. ]The proportion of patients experiencing recognised complications of ECMO treatment.
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 2, 2019 | ||||||
| First Posted Date | June 7, 2019 | ||||||
| Last Update Posted Date | August 20, 2019 | ||||||
| Actual Study Start Date | December 1, 2011 | ||||||
| Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Survival at ECMO ICU discharge [ Time Frame: Up to 90 days. ] The proportion of patients who are alive at discharge from the ICU at the treating ECMO centre.
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
|
||||||
| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study. | ||||||
| Official Title | Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study. | ||||||
| Brief Summary |
This is an observational study of outcomes of the NHS England-commissioned national respiratory ECMO service, which has been active at six centres since December 2011. The primary outcome of interest is the number of patients who survive to ICU discharge at the ECMO centre. The study also aims to identify factors predictive of outcome. |
||||||
| Detailed Description |
Recent randomised and observational studies suggest there may be a role for extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory failure that have not responded to conventional measures. In 2011, NHS England commissioned a national service to provide ECMO for severe respiratory failure at six centres across the country. Patients with severe respiratory failure are referred to the network if conventional measures are unsuccessful, and if accepted are transferred to an ECMO centre for specialist care. The criteria for admission is at the discretion of clinicians at each centre. The NHS ECMO registry has been created by cross-referencing data submitted to the Extracorporeal Life Support Organisation (ELSO) in Ann Arbor, Michigan, with a tracker document identifying patients treated within the network. Analysis has been undertaken from December 2018 to March 2019. |
||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | All patients who received ECMO as part of the NHS England-commissioned national respiratory ECMO service between 1st December 2011 and 31st December 2017. | ||||||
| Condition | Acute Respiratory Failure | ||||||
| Intervention | Device: Extracorporeal Membrane Oxygenation
ECMO provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into either the venous or arterial circulation dependent on configuration.
|
||||||
| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Warren A, Chiu YD, Villar SS, Fowles JA, Symes N, Barker J, Camporota L, Harvey C, Ledot S, Scott I, Vuylsteke A; NHS England-commissioned National ECMO Service. Outcomes of the NHS England National Extracorporeal Membrane Oxygenation Service for adults with respiratory failure: a multicentre observational cohort study. Br J Anaesth. 2020 Sep;125(3):259-266. doi: 10.1016/j.bja.2020.05.065. Epub 2020 Jul 28. | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
1205 | ||||||
| Original Actual Enrollment | Same as current | ||||||
| Actual Study Completion Date | March 31, 2018 | ||||||
| Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
| Sex/Gender |
|
||||||
| Ages | 16 Years and older (Child, Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Not Provided | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03979222 | ||||||
| Other Study ID Numbers | ECMO-001 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement |
|
||||||
| Responsible Party | Alex Warren, University of Cambridge | ||||||
| Study Sponsor | University of Cambridge | ||||||
| Collaborators |
|
||||||
| Investigators | Not Provided | ||||||
| PRS Account | University of Cambridge | ||||||
| Verification Date | August 2019 | ||||||
