Helmet Ventilation During Self-Paced Walking Test
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedStudy Start
First participant enrolled
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedSeptember 30, 2021
September 1, 2021
7 months
November 6, 2019
September 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
6WMD
Walking distance of six minute walking test
2 days
Secondary Outcomes (3)
Heart rate
2 days
Respiratory rate
2 days
modified Borg dyspnea scale
2 days
Study Arms (2)
HV
EXPERIMENTAL6MWT with helmet ventilation
Control
NO INTERVENTION6MWT alone according to ATS guideline
Interventions
We will apply non-invasive positive pressure ventilation via a helmet as interface
Eligibility Criteria
You may qualify if:
- Patents with COPD who confirm by pulmonary function test
You may not qualify if:
- COPD AE within 3 months
- Diagnosed neuromuscular disease
- Unable to perform 6-MWT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352, Taiwan
Related Publications (4)
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.
PMID: 27179847BACKGROUNDPatel 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.
PMID: 29595563BACKGROUNDDreher 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. doi: 10.1183/09031936.00075806. Epub 2007 Mar 1.
PMID: 17331969BACKGROUNDChao KY, Liu WL, Nassef Y, Lai PZ, Wang JS. A pilot crossover trial assessing the exercise performance patients chronic obstructive pulmonary disease. Sci Rep. 2022 Mar 9;12(1):4158. doi: 10.1038/s41598-022-07698-z.
PMID: 35264615DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Lun Liu, MD
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Leader of Respiratory Therapist
Study Record Dates
First Submitted
November 6, 2019
First Posted
November 7, 2019
Study Start
July 14, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
September 30, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share