Trial Outcomes & Findings for Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS (NCT NCT01272882)

Results Overview

Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

At the start of monitoring once the patient was consented and enrolled.

Results posted on

2017-05-25

Participant Flow

Intensive care units

No pre-assignment details to note.

Participant milestones

Participant milestones
Measure	Adults With ARDS or ALI Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrical Impedance Tomography (EIT) Monitoring in Adults With ALI or ARDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With ARDS or ALI n=13 Participants Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 22 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: At the start of monitoring once the patient was consented and enrolled.

Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.

Outcome measures

Outcome measures
Measure	Adults With ARDS or ALI n=13 Participants Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients	13 Patients successfully monitored with EIT

Adverse Events

Adults With ARDS or ALI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerard Fulda

ChristianaCHS

Phone: 302-733-4260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place