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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669863
• Other study ID #: MHH-6208
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 15, 2012
• Last updated: April 22, 2015
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2015
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics committee Hannover Medical School
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

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

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Oxygenation Index During Application of ECMO	Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay	Duration of ICU stay	No
Primary	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	Yes
Secondary	Number of Participants Who Presented With ECMO-Related Complications	ECMO-related complications	Duration of ICU stay	Yes