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

This study has been completed.
Information provided by (Responsible Party):
Marius Hoeper, MD, Hannover Medical School Identifier:
First received: August 15, 2012
Last updated: April 22, 2015
Last verified: March 2015
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure

Condition Intervention Phase
ARDS Device: ECMO Procedure: ECMO in non-intubated patients Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study

Resource links provided by NLM:

Further study details as provided by Marius Hoeper, MD, Hannover Medical School:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Number of Participants Who Presented With ECMO-Related Complications [ Time Frame: Duration of ICU stay ]
    ECMO-related complications

Other Outcome Measures:
  • 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

Enrollment: 6
Study Start Date: August 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Use of ECMO in non-intubated patients
ECMO will be used in non-intubated patients with ARDS
Device: ECMO
Use of veno-venous ECMO in non-intubated patients with ARDS
Procedure: ECMO in non-intubated patients
Use of veno-venous ECMO in non-intubated patients with ARDS

Detailed Description:
Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid endotracheal intubation and mechanical ventilation

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%
  Contacts and Locations
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Please refer to this study by its identifier: NCT01669863

Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Principal Investigator: Marius M Hoeper, MD Hannover Medical School
  More Information

Responsible Party: Marius Hoeper, MD, Principle Investigator, Hannover Medical School 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

Keywords provided by Marius Hoeper, MD, Hannover Medical School:

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Lung Injury processed this record on August 17, 2017