Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Noninvasive Estimation of Work of Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867228
Recruitment Status : Terminated (Resources to be able to screen and enroll patients are no longer available.)
First Posted : August 15, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Respironics, California, Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: changes in ventilator settings Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Noninvasive Estimation of Work of Breathing
Actual Study Start Date : September 2016
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 4, 2017


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Accuracy of lung mechanics measurements [ Time Frame: Immediate ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867228


Locations
Layout table for location information
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Respironics, California, Inc.
Investigators
Layout table for investigator information
Principal Investigator: David H Chong, MD Columbia University

Publications of Results:
Layout table for additonal information
Responsible Party: Respironics, California, Inc.
ClinicalTrials.gov Identifier: NCT02867228     History of Changes
Other Study ID Numbers: IRB-AAAP8801
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury