Study Stopped
Resources to be able to screen and enroll patients are no longer available.
Noninvasive Estimation of Work of Breathing
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2017
CompletedJuly 27, 2017
August 1, 2016
8 months
August 10, 2016
July 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of lung mechanics measurements
Immediate
Study Arms (1)
Single Observational Group
OTHERPatients receiving mechanical ventilation and subject to the intervention: changes in ventilator settings.
Interventions
Ventilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate).
Eligibility Criteria
You may qualify if:
- Adult medical/surgical ICU patients (Age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (PSV).
You may not qualify if:
- Prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (2)
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.
PMID: 7587438RESULTKirton 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.
PMID: 8813268RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David H Chong, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 15, 2016
Study Start
September 1, 2016
Primary Completion
May 4, 2017
Study Completion
May 4, 2017
Last Updated
July 27, 2017
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share