Noninvasive Estimation of Work of Breathing

July 25, 2017 updated by: Respironics, California, Inc.
This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only. Vent settings will be adjusted to test accuracy over a range of respiratory support conditions.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult medical/surgical ICU patients (Age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (PSV).

Exclusion Criteria:

  • Prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Observational Group
Patients receiving mechanical ventilation and subject to the intervention: changes in ventilator settings.
Other: changes in ventilator settings
Ventilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of lung mechanics measurements
Time Frame: Immediate
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respironics, California, Inc.

Investigators

  • Principal Investigator: David H Chong, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

May 4, 2017

Study Completion (Actual)

May 4, 2017

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-AAAP8801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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