Phase 2
N=6
Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)
ARDS
Bottom Line
View on ClinicalTrials.gov: NCT01669863 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants That Did Not Require Endotrachael Intubation — 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ECMO (Device); ECMO in non-intubated patients (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hannover Medical School
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Did Not Require Endotrachael Intubation |
3 | — |
| SECONDARY Number of Participants Who Presented With ECMO-Related Complications |
1 | — |
Summary
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure
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 10 l/min not tolerating noninvasive ventilation, or
- PaO2/FiO2 2, 0; aPTT > 60s, Platelet count 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 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 50%
Data sourced from ClinicalTrials.gov (NCT01669863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.