ARDS
Conditions
Keywords
ARDS
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
Interventions
DEVICEECMO
Use of veno-venous ECMO in non-intubated patients with ARDS
PROCEDUREECMO in non-intubated patients
Use of veno-venous ECMO in non-intubated patients with ARDS
Sponsors
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Did Not Require Endotrachael Intubation | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Presented With ECMO-Related Complications | Duration of ICU stay | ECMO-related complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxygenation Index During Application of ECMO | Duration of ICU stay | Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay |
Countries
Germany
Participant flow
Recruitment details
6 patients recruited as planned
Participants by arm
| Arm | Count |
|---|---|
| Use of ECMO in Non-intubated Patients ECMO group | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Use of ECMO in Non-intubated Patients |
|---|---|
| Age, Customized | 60 years STANDARD_DEVIATION 10 |
| Region of Enrollment Germany | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
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.
Time frame: Duration of ICU stay
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Use of ECMO in Non-intubated Patients | Number of Participants That Did Not Require Endotrachael Intubation | 3 participants |
Secondary
Number of Participants Who Presented With ECMO-Related Complications
ECMO-related complications
Time frame: Duration of ICU stay
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Use of ECMO in Non-intubated Patients | Number of Participants Who Presented With ECMO-Related Complications | 1 participants |
Other Pre-specified
Change in Oxygenation Index During Application of ECMO
Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay
Time frame: Duration of ICU stay
Population: Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.