Noninvasive Estimation of Work of Breathing

• Sponsor: Respironics, California, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02867228
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Other: changes in ventilator settings	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Noninvasive Estimation of Work of Breathing
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: May 4, 2017
• Actual Study Completion Date: May 4, 2017

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Accuracy of lung mechanics measurements [Immediate]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Respironics, California, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Respironics, California, Inc.
• ClinicalTrials.gov Identifier: NCT02867228
• Other Study ID Numbers: IRB-AAAP8801
• First Posted: Aug 15, 2016
• Last Update Posted: Jul 27, 2017
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Jul 27, 2017