Efficacy of High Flow Therapy in COPD At Home

COPD Clinical Trial

— EHFT  

Official title:

Efficacy of High Flow Therapy in COPD At Home

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02230020
• Other study ID #: NA_00084508
• Status: Terminated
• Phase: N/A
• First received: August 29, 2014
• Last updated: August 7, 2017
• Start date: August 15, 2013
• Est. completion date: December 13, 2015

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 13, 2015
• Est. primary completion date: December 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 1. Consenting adults over the age of 18 with COPD

Exclusion Criteria:

• 1. Apnea Hypopnea Index>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:

1. myocardial infarction in past 3 months

2. revascularization procedure in past 3 months

3. implanted cardiac pacemaker or ICD

4. unstable arrhythmias

5. congestive heart failure with ejection fraction < 40%

6. uncontrolled hypertension (BP > 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as:

1. Jaundice

2. ascites

3. history of recurrent gastrointestinal bleeding

4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons:

1. Pain control (besides NSAIDs)

2. Sleep medication

3. Benzodiazepines

4. Methadone

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Nasal High Flow

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function	Spirometry will be performed before and after each sleep study	Baseline and 1 month
Primary	Dyspnea score	Borg scale score before and after each sleep study	Baseline and 1 month
Primary	Sleep quality	Sleep architecture assessed from sleep studies	Baseline and 1 month
Primary	Quality of life	St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath	Baseline and 1 month