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

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ClinicalTrials.gov Identifier: NCT01669863
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : April 23, 2015
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Marius Hoeper, MD, Hannover Medical School

Brief Summary:
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure

Condition or disease Intervention/treatment Phase
ARDS Device: ECMO Procedure: ECMO in non-intubated patients Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Number of Participants Who Presented With ECMO-Related Complications [ Time Frame: Duration of ICU stay ]
    ECMO-related complications


Other Outcome Measures:
  1. 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



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

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669863


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

Responsible Party: Marius Hoeper, MD, Principle Investigator, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01669863     History of Changes
Other Study ID Numbers: MHH-6208
First Posted: August 21, 2012    Key Record Dates
Results First Posted: April 23, 2015
Last Update Posted: April 23, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Lung Injury