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

Hannover Medical School (MHH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: ARDS

Treatments: Device: ECMO; Procedure: ECMO in non-intubated patients

Study type: Interventional

Funder types: Other

Identifiers

NCT01669863

MHH-6208

Details and patient eligibility

About

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

Full description

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Use of ECMO in non-intubated patients

Experimental group

Description:

ECMO will be used in non-intubated patients with ARDS

Treatment:

Procedure: ECMO in non-intubated patients

Device: ECMO