Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Respiratory Distress Syndrome
  • Extracorporeal Membrane Oxygenation
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show th...

Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.

Tracking Information

NCT #
NCT04754854
Collaborators
Not Provided
Investigators
Principal Investigator: Martin Russ, Dr. med. Charite University Hospital Berlin Principal Investigator: Philipp A Pickerodt, Dr. med. Charite University Hospital Berlin Principal Investigator: Vladimir Skrypnikov, Dr. med. Charite University Hospital Berlin Principal Investigator: Steffen Weber-Carstens, Prof. Dr. med. Charite University Hospital Berlin