Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-07-14
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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HV
6MWT with helmet ventilation
Helmet vetilation
We will apply non-invasive positive pressure ventilation via a helmet as interface
Control
6MWT alone according to ATS guideline
No interventions assigned to this group
Interventions
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Helmet vetilation
We will apply non-invasive positive pressure ventilation via a helmet as interface
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diagnosed neuromuscular disease
* Unable to perform 6-MWT
20 Years
ALL
No
Sponsors
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Fu Jen Catholic University
OTHER
Responsible Party
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Ke-Yun, Chao
Leader of Respiratory Therapist
Principal Investigators
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Wen-Lun Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
Locations
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Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, , Taiwan
Countries
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References
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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. doi: 10.1183/09031936.00075806. Epub 2007 Mar 1.
Chao 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.
Other Identifiers
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C108032
Identifier Type: -
Identifier Source: org_study_id
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