search
Back to results

Noninvasive Estimation of Work of Breathing

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
changes in ventilator settings
Sponsored by
Respironics, California, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Observational Group

Arm Description

Patients receiving mechanical ventilation and subject to the intervention: changes in ventilator settings.

Outcomes

Primary Outcome Measures

Accuracy of lung mechanics measurements

Secondary Outcome Measures

Full Information

First Posted
August 10, 2016
Last Updated
July 25, 2017
Sponsor
Respironics, California, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02867228
Brief Title
Noninvasive Estimation of Work of Breathing
Official Title
Noninvasive Estimation of Work of Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Resources to be able to screen and enroll patients are no longer available.
Study Start Date
September 2016 (Actual)
Primary Completion Date
May 4, 2017 (Actual)
Study Completion Date
May 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respironics, California, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Observational Group
Arm Type
Other
Arm Description
Patients receiving mechanical ventilation and subject to the intervention: changes in ventilator settings.
Intervention Type
Other
Intervention Name(s)
changes in ventilator settings
Intervention Description
Ventilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate).
Primary Outcome Measure Information:
Title
Accuracy of lung mechanics measurements
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Chong, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7587438
Citation
Banner MJ, Kirby RR, Kirton OC, DeHaven CB, Blanch PB. Breathing frequency and pattern are poor predictors of work of breathing in patients receiving pressure support ventilation. Chest. 1995 Nov;108(5):1338-44. doi: 10.1378/chest.108.5.1338.
Results Reference
result
PubMed Identifier
8813268
Citation
Kirton OC, DeHaven CB, Hudson-Civetta J, Morgan JP, Windsor J, Civetta JM. Re-engineering ventilatory support to decrease days and improve resource utilization. Ann Surg. 1996 Sep;224(3):396-402; discussion 402-4. doi: 10.1097/00000658-199609000-00016.
Results Reference
result

Learn more about this trial

Noninvasive Estimation of Work of Breathing

We'll reach out to this number within 24 hrs