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

August 28, 2023 updated by: Armin N. Flinspach, Goethe University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) for respiratory failure in acute respiratory distress syndrome (ARDS). And in addition required mechanical cardiovascular resuscitation treatment during existing therapy with veno-venous extracorporeal membrane oxygenation (vv-ECMO).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of mechanical cardiovascular resuscitation
Time Frame: During the intensive care stay ( usually between 2 and 8 weeks)
Survival of mechanical cardiovascular resuscitation
During the intensive care stay ( usually between 2 and 8 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

April 16, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR during VV-ECMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing patient data with third parties is subject to national and local law restrictions and regrettably not possible.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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