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

NCT ID: NCT01669863

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-04-30

Brief Summary

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

Detailed Description

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

Conditions

ARDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Use of ECMO in non-intubated patients

ECMO will be used in non-intubated patients with ARDS

Group Type: EXPERIMENTAL

ECMO

Intervention Type: DEVICE

Use of veno-venous ECMO in non-intubated patients with ARDS

ECMO in non-intubated patients

Intervention Type: PROCEDURE

Use of veno-venous ECMO in non-intubated patients with ARDS

Interventions

ECMO

Use of veno-venous ECMO in non-intubated patients with ARDS

Intervention Type: DEVICE

ECMO in non-intubated patients

Use of veno-venous ECMO in non-intubated patients with ARDS

Intervention Type: PROCEDURE

Eligibility 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

• 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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Marius Hoeper, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marius M Hoeper, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Hannover Medical School

Hanover, , Germany

Countries

Germany

Other Identifiers

MHH-6208

Identifier Type: -

Identifier Source: org_study_id