Helmet Ventilation During Self-Paced Walking Test

• Sponsor: Fu Jen Catholic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04156724
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: Helmet vetilation	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Helmet Ventilation During Self-Paced Walking Test With Chronic Obstructive Pulmonary Disease
• Actual Study Start Date: Jul 14, 2020
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HV 6MWT with helmet ventilation	Device: Helmet vetilation; We will apply non-invasive positive pressure ventilation via a helmet as interface
No Intervention: Control 6MWT alone according to ATS guideline

Outcome Measures

Primary Outcome Measures

1. 6WMD [2 days]

   Walking distance of six minute walking test

Secondary Outcome Measures

1. Heart rate [2 days]

   Heart rate of six minute walking test

2. Respiratory rate [2 days]

   Respiratory rate of six minute walking test

3. modified Borg dyspnea scale [2 days]

   A self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City		Taiwan	24352

Sponsors and Collaborators

• Fu Jen Catholic University

Investigators

• Principal Investigator: Wen-Lun Liu, MD, Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Ke-Yun, Chao, Leader of Respiratory Therapist, Fu Jen Catholic University
• ClinicalTrials.gov Identifier: NCT04156724
• Other Study ID Numbers: C108032
• First Posted: Nov 7, 2019
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Sep 30, 2021