- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01669863
Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)
April 22, 2015 updated by: Marius Hoeper, MD, Hannover Medical School
Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid endotracheal intubation and mechanical ventilation
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 1
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
-
-
-
Hannover, Germany, 30625
- Hannover Medical School
-
-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients aged 18-75 yrs with acute respiratory failure due to ARDS or pneumonia fulfilling standard criteria for endotracheal intubation
- Severe and progressive hypoxemia, i.e. PaO2 < 60 mmHg or SaO2 < 90% on O2 > 10 l/min not tolerating noninvasive ventilation, or
- PaO2/FiO2 < 200 not improving or deteriorating on noninvasive ventilation, or
- Respiratory distress and hypoxemia not fulfilling the criteria above with clinical impression of the ICU attending that intubation and mechanical ventilation are mandated
- Patient considered eligible by at least two investigators of this study
Exclusion Criteria:
- Patient does not fulfill the inclusion criteria
- Uncontrolled malignancy
- Severe and untreatable coagulation or bleeding disorders (INR > 2,0; aPTT > 60s, Platelet count < 50.000/µl, all after substitution)
- Stroke within the past 3 months
- Uncontrolled sepsis or septic shock
- Multiorgan failure involving > 2 organ systems
- Norepinephrine dose > 1 mg/h
- Hyperdynamic circulation, indicated by cardiac index > 4.0 l/min/m2 (measured by PiCCO or Swan-Ganz catheter), or SvO2 > 80%
- Cardiac pump failure, indicated by echocardiography (EF < 40%), PiCCO or Swan Ganz catheter (CI < 2,5 l/min/m2 despite adequate volume management), or SvO2 < 50% (provided Hb > 9,0 g/dl and SaO2 > 90%), or the need for inotropes (dobutamine, epinephrine, levosimendan)
- Clinical or echocardiographic signs of pulmonary hypertension with right ventricular dysfunction
- APACHE-II score15 < 25
- Other conditions suggesting that the patient would benefit from intubation and mechanical ventilation
- Severe neurological disorders
- Estimated mortality due to severity of acute and/or underlying illness > 50%
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Use of ECMO in non-intubated patients
ECMO will be used in non-intubated patients with ARDS
|
Use of veno-venous ECMO in non-intubated patients with ARDS
Use of veno-venous ECMO in non-intubated patients with ARDS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants That Did Not Require Endotrachael Intubation
Time Frame: Duration of ICU stay
|
- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive.
In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.
|
Duration of ICU stay
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Presented With ECMO-Related Complications
Time Frame: Duration of ICU stay
|
ECMO-related complications
|
Duration of ICU stay
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Oxygenation Index During Application of ECMO
Time Frame: Duration of ICU stay
|
Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay
|
Duration of ICU stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marius M Hoeper, MD, Hannover Medical School
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
August 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
August 20, 2012
First Posted (Estimate)
August 21, 2012
Study Record Updates
Last Update Posted (Estimate)
April 23, 2015
Last Update Submitted That Met QC Criteria
April 22, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MHH-6208
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.
Clinical Trials on ARDS
-
National University Health System, SingaporeActive, not recruiting
-
King Abdul Aziz Specialist HospitalCompleted
-
Southeast University, ChinaCompleted
-
Magni FedericoUnknown
-
Wolfson Medical CenterUnknown
-
Southeast University, ChinaFirst Affiliated Hospital of Wannan Medical CollegeRecruiting
-
University Hospital, AngersCompleted
Clinical Trials on ECMO
-
University of MichiganCompletedRespiratory FailureUnited States
-
Kepler University HospitalCompletedARDS Due to Disease Caused by SARS Co-V-2Austria
-
Hamad Medical CorporationRecruitingCardiogenic Shock | Extracorporeal Membrane Oxygenation ComplicationQatar
-
Nanjing Medical UniversityRecruitingHeart Failure | Cardiac Arrest | Acute Respiratory Distress Syndrome | Cardiogenic Shock | Acute Respiratory FailureChina
-
University Hospital TuebingenNot yet recruitingAcute Respiratory Distress SyndromeGermany
-
Jessa HospitalCompleted
-
Children's Hospital of Fudan UniversityChinese PLA General Hospital; Guangdong Provincial People's Hospital; The Children... and other collaboratorsCompleted
-
University of Milano BicoccaOspedale San Gerardo. S.S.U.E.M. 118 Brianza; Ospedale San Gerardo. Terapia...Unknown
-
Assistance Publique - Hôpitaux de ParisMaquet CardiovascularCompletedCardiac Arrest | Sudden DeathFrance
-
Children's Hospital of Fudan UniversityRecruitingExtracorporeal Membrane Oxygenation | Child, OnlyChina