Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.

Sponsor

Goethe University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05342363

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. We are aiming to conduct a retrospective observational study of all vv-ECMO patients treated at our ARDS centre.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Resuscitation Venovenous Extracorporeal Membrane Oxygenation

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
cardiopulmonary resuscitation during treatment with extracorporeal membrane oxygenation Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) during the retrospective observation period who required mechanical cardiovascular resuscitation (CPR) during their treatment.
Treatment with extracorporeal membrane oxygenation without resuscitation Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) without the need for cardiovascular resuscitation during the retrospective observation period.

Outcome Measures

Primary Outcome Measures

Survival of mechanical cardiovascular resuscitation [During the intensive care stay ( usually between 2 and 8 weeks)]
Survival of mechanical cardiovascular resuscitation

Secondary Outcome Measures

Incidence of cardiovascular resuscitation i [During the observation period 2019-2022]
Incidence of cardiovascular resuscitation in patients treated with venovenous extracorporeal membrane oxygenation.
Complications of resuscitation treatments [During the intensive care stay ( usually between 2 and 8 weeks)]
Complications of cardiovascular resuscitation in patients treated with venovenous extracorporeal membrane oxygenation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) due to respiratory failure during acute respiratory distress syndrome (ARDS).

Exclusion Criteria:

Patients treated with veno-arterial extracorporeal membrane oxygenation (va-ECMO)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Frankfurt	Frankfurt	Hessen	Germany	60590

Sponsors and Collaborators

Goethe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Armin N. Flinspach, Physician, Goethe University

ClinicalTrials.gov Identifier:

NCT05342363

Other Study ID Numbers:

CPR during VV-ECMO

First Posted:

Apr 22, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Aug 8, 2022