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

Phase 1

Completed

• Conditions: ARDS
• Interventions: Device: ECMO; Procedure: ECMO in non-intubated patients

• Registration Number: NCT01669863
• Lead Sponsor: Hannover Medical School

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-03
• Results First Submitted: 2015-03-17
• Results First Submitted QC: 2015-04-22
• Last Update Submitted: 2015-04-22
• Results First Posted: 2015-04-23
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of ECMO in non-intubated patients	ECMO	ECMO will be used in non-intubated patients with ARDS
Use of ECMO in non-intubated patients	ECMO in non-intubated patients	ECMO will be used in non-intubated patients with ARDS

Primary Outcome Measures

Name	Time	Method
Number of Participants That Did Not Require Endotrachael Intubation	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

Name	Time	Method
Number of Participants Who Presented With ECMO-Related Complications	Duration of ICU stay	ECMO-related complications

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany