Noninvasive Estimation of Work of Breathing

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Noninvasive Estimation of Work of Breathing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02867228
• Other study ID #: IRB-AAAP8801
• Status: Terminated
• Phase: N/A
• First received: August 10, 2016
• Last updated: July 25, 2017
• Start date: September 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: August 2016
• Source: Respironics, California, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• changes in ventilator settings
Ventilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate).

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Respironics, California, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of lung mechanics measurements		Immediate