Helmet Ventilation During Self-Paced Walking Test

COPD Clinical Trial

Official title:

Helmet Ventilation During Self-Paced Walking Test With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156724
• Other study ID #: C108032
• Status: Completed
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2021
• Source: Fu Jen Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Description:

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. Symptoms of COPD may contribute to activity restriction, deconditioning and exercise intolerance. Non-invasive positive pressure ventilation (NIPPV) has been shown to improve exercise intolerance and health-related quality of life in patients with severe COPD. Helmet ventilation (HV) is a new option for NIPPV to alternative to nasal or face mask. A study which published on JAMA demonstrated the feasibility and benefits of HV. The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patents with COPD who confirm by pulmonary function test

Exclusion Criteria:

• COPD AE within 3 months

• Diagnosed neuromuscular disease

• Unable to perform 6-MWT

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Helmet vetilation
We will apply non-invasive positive pressure ventilation via a helmet as interface

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Dreher M, Storre JH, Windisch W. Noninvasive ventilation during walking in patients with severe COPD: a randomised cross-over trial. Eur Respir J. 2007 May;29(5):930-6. Epub 2007 Mar 1. — View Citation

Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124. — View Citation

Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6WMD	Walking distance of six minute walking test	2 days
Secondary	Heart rate	Heart rate of six minute walking test	2 days
Secondary	Respiratory rate	Respiratory rate of six minute walking test	2 days
Secondary	modified Borg dyspnea scale	A self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse	2 days