Trial Outcomes & Findings for Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS) (NCT NCT01669863)

Results Overview

\- 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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Duration of ICU stay

Results posted on

2015-04-23

Participant Flow

6 patients recruited as planned

Participant milestones

Participant milestones
Measure	Use of ECMO in Non-intubated Patients ECMO used in non-intubated patients with ARDS ECMO ECMO in non-intubated patients
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Use of ECMO in Non-intubated Patients n=6 Participants ECMO group
Age, Customized	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Use of ECMO in Non-intubated Patients n=6 Participants ECMO will be used in non-intubated patients with ARDS ECMO ECMO in non-intubated patients
Number of Participants That Did Not Require Endotrachael Intubation	3 participants

SECONDARY outcome

Timeframe: Duration of ICU stay

ECMO-related complications

Outcome measures

Outcome measures
Measure	Use of ECMO in Non-intubated Patients n=6 Participants ECMO will be used in non-intubated patients with ARDS ECMO ECMO in non-intubated patients
Number of Participants Who Presented With ECMO-Related Complications	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Use of ECMO in Non-intubated Patients

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Use of ECMO in Non-intubated Patients n=6 participants at risk Patients on ECMO
Respiratory, thoracic and mediastinal disorders Accidental ECMO line removal	16.7% 1/6

Other adverse events

Adverse event data not reported

Additional Information

Dr Marius Hoeper

Hannover Medical School

Phone: 00495115323530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place