NCT01669863

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 23, 2015

Completed
Last Updated

April 23, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

August 15, 2012

Results QC Date

March 17, 2015

Last Update Submit

April 22, 2015

Conditions

ARDS

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants Who Presented With ECMO-Related Complications

    Duration of ICU stay

Other Outcomes (1)

  • Change in Oxygenation Index During Application of ECMO

    Duration of ICU stay

Study Arms (1)

Use of ECMO in non-intubated patients

EXPERIMENTAL

ECMO will be used in non-intubated patients with ARDS

Device: ECMOProcedure: ECMO in non-intubated patients

Interventions

ECMODEVICE

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

Use of ECMO in non-intubated patients
ECMO in non-intubated patientsPROCEDURE

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

Use of ECMO in non-intubated patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

MeSH Terms

Interventions

Extracorporeal Membrane Oxygenation

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Results Point of Contact

Title
Dr Marius Hoeper
Organization
Hannover Medical School
hoeper.marius@mh-hannover.de
00495115323530

Study Officials

  • Marius M Hoeper, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 21, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 23, 2015

Results First Posted

April 23, 2015

Record last verified: 2015-03

Locations

DE(1)