Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marius Hoeper, MD, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01669863
First received: August 15, 2012
Last updated: April 22, 2015
Last verified: March 2015
Results First Received: March 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: ARDS
Interventions: Device: ECMO
Procedure: ECMO in non-intubated patients

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
6 patients recruited as planned

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Use of ECMO in Non-intubated Patients

ECMO used in non-intubated patients with ARDS

ECMO

ECMO in non-intubated patients


Participant Flow:   Overall Study
    Use of ECMO in Non-intubated Patients  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Use of ECMO in Non-intubated Patients ECMO group

Baseline Measures
    Use of ECMO in Non-intubated Patients  
Number of Participants  
[units: participants]
  6  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  60  ± 10  
Gender  
[units: participants]
 
Female     1  
Male     5  
Region of Enrollment  
[units: participants]
 
Germany     6  



  Outcome Measures
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1.  Primary:   Number of Participants That Did Not Require Endotrachael Intubation   [ Time Frame: Duration of ICU stay ]

2.  Secondary:   Number of Participants Who Presented With ECMO-Related Complications   [ Time Frame: Duration of ICU stay ]

3.  Other Pre-specified:   Change in Oxygenation Index During Application of ECMO   [ Time Frame: Duration of ICU stay ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Marius Hoeper
Organization: Hannover Medical School
phone: 00495115323530
e-mail: hoeper.marius@mh-hannover.de


No publications provided


Responsible Party: Marius Hoeper, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01669863     History of Changes
Other Study ID Numbers: MHH-6208
Study First Received: August 15, 2012
Results First Received: March 17, 2015
Last Updated: April 22, 2015
Health Authority: Germany: Ethics committee Hannover Medical School