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

August 15, 2012
April 22, 2015
August 2012
April 2013   (final data collection date for primary outcome measure)
Number of Participants That Did Not Require Endotrachael Intubation [ Time Frame: Duration of ICU stay ] [ Designated as safety issue: Yes ]
- 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.
Prevention of endotrachael intubation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- 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.
Complete list of historical versions of study NCT01669863 on ClinicalTrials.gov Archive Site
Number of Participants Who Presented With ECMO-Related Complications [ Time Frame: Duration of ICU stay ] [ Designated as safety issue: Yes ]
ECMO-related complications
Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
ECMO-related complications
Change in Oxygenation Index During Application of ECMO [ Time Frame: Duration of ICU stay ] [ Designated as safety issue: No ]
Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay
Oxygenation index [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
regular assessment during ICU stay
 
Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)
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

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

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: Use of ECMO in non-intubated patients
ECMO will be used in non-intubated patients with ARDS
Interventions:
  • Device: ECMO
  • Procedure: ECMO in non-intubated patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2013
April 2013   (final data collection date for primary outcome measure)

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%
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01669863
MHH-6208
No
Marius Hoeper, MD, Hannover Medical School
Hannover Medical School
Not Provided
Principal Investigator: Marius M Hoeper, MD Hannover Medical School
Hannover Medical School
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP