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

Study Overview
=================
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

Official Title
-----------------
Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study

Conditions
-----------------
ARDS

Intervention / Treatment
-----------------
* Device: ECMO
* Procedure: ECMO in non-intubated patients


Participation Criteria
=================
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 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%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of ECMO in non-intubated patients<br>ECMO will be used in non-intubated patients with ARDS | Device: ECMO<br>* Use of veno-venous ECMO in non-intubated patients with ARDS<br>Procedure: ECMO in non-intubated patients<br>* Use of veno-venous ECMO in non-intubated patients with ARDS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Did Not Require Endotrachael Intubation | - 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. | Duration of ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Presented With ECMO-Related Complications | ECMO-related complications | Duration of ICU stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS