Clinical trial NCT01669863: Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)
Official title: Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ARDS
Keywords: ARDS
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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%

Primary outcomes:
measure: Number of Participants That Did Not Require Endotrachael Intubation
timeFrame: Duration of ICU stay
Secondary outcomes:
measure: Number of Participants Who Presented With ECMO-Related Complications
timeFrame: Duration of ICU stay
Other outcomes:
measure: Change in Oxygenation Index During Application of ECMO
timeFrame: Duration of ICU stay
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Marius M Hoeper, MD
role: PRINCIPAL_INVESTIGATOR
References: