Helmet Ventilation During Walking Test

Overview

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.

Full Title of Study: “Helmet Ventilation During Walking Test With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

Interventions

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

Arms, Groups and Cohorts

  • Experimental: HV
    • 6MWT with helmet ventilation
  • No Intervention: Control
    • 6MWT alone according to ATS guideline

Clinical Trial Outcome Measures

Primary Measures

  • 6WMD
    • Time Frame: 2 days
    • Walking distance of six minute walking test

Secondary Measures

  • Heart rate
    • Time Frame: 2 days
    • Heart rate of six minute walking test
  • Respiratory rate
    • Time Frame: 2 days
    • Respiratory rate of six minute walking test
  • modified Borg dyspnea scale
    • Time Frame: 2 days
    • A self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fu Jen Catholic University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ke-Yun, Chao, Leader of Respiratory Therapist – Fu Jen Catholic University

References

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.

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.

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.

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