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Completed

NCT Number: NCT01669863

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

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hannover Medical School

Hanover, 30625, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

ECMO

Device

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

ECMO in non-intubated patients

Procedure

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

Primary outcomes

  1. Number of Participants That Did Not Require Endotrachael Intubation

    Time frame: Duration of ICU stay

    • 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.

Secondary outcomes

  1. Number of Participants Who Presented With ECMO-Related Complications

    Time frame: Duration of ICU stay

    ECMO-related complications

Other outcomes

  1. Change in Oxygenation Index During Application of ECMO

    Time frame: Duration of ICU stay

    Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2012
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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