NCT01272882

Brief Summary

Electrical impedance tomography (EIT) monitoring has been researched as a method to determine the spatial impedance distribution in a body cross section, but has yet to become an established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement of both global and regional ventilation. Recently, there has been evidence that EIT monitoring has great potential to become a non-invasive bedside tool for assessment of regional lung ventilation without documented hazards. Potential applications include any adult patients in acute respiratory failure. Data collected from this research may contribute to improved patient safety outcomes. PURPOSE: The purpose of this pilot study is to examine the feasibility of using the EIT monitor in intensive care unit (ICU) setting on patients with acute respiratory failure and to compare the EIT monitor data to standard of care patient assessments. It is hypothesized that the EIT monitor, when applied to adults in acute respiratory failure, will correlate with conventional standard of care assessments for these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

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

May 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 7, 2013

Completed
Last Updated

May 25, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

January 3, 2011

Results QC Date

October 31, 2012

Last Update Submit

April 27, 2017

Conditions

Acute Lung Injury (ALI)ARDS

Outcome Measures

Primary Outcomes (1)

  • Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients

    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.

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

Study Arms (1)

Adults with ARDS or ALI

EXPERIMENTAL

Adults with PaO2/FiO2 ratio less than 300. Consented patients will be placed on EIT monitor. The only intervention is the addition of Electrical Impedance Tomography monitoring using the Chest belt with 16 electrodes connected to the EIT device. No changes to standard patient care will occur other than collecting EIT monitor data.

Device: Electrical Impedance Tomography monitoring

Interventions

Electrical Impedance Tomography monitoringDEVICE

Chest belt with 16 electrodes connected to the EIT device

Adults with ARDS or ALI

Eligibility Criteria

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

You may qualify if:

  • Patients will be included in this study if the following criteria have been met:
  • Males and females \> 18 years old (non-pregnant, non-lactating females).
  • Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ratio \< 300 torr.
  • Signed informed consent has been obtained.

You may not qualify if:

  • Females who are pregnant or lactating.
  • Patients with skin abrasions or wounds in the chest area.
  • Patients receiving dialysis.
  • Patients with pacemakers or paced EKG rhythms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Gerard Fulda
Organization
ChristianaCHS
gfulda@christianacare.org
302-733-4260

Study Officials

  • John S Emberger, BS

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

  • Vinay Maheshwari, MD

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

  • Joel M Brown, BS

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 10, 2011

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 25, 2017

Results First Posted

January 7, 2013

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

IPD data will not be shared

Locations

US(1)