Helmet Ventilation in Acute Hypercapnic Respiratory Failure
NCT ID: NCT01645358
Last Updated: 2014-10-07
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
PHASE4
80 participants
INTERVENTIONAL
2012-07-31
2014-09-30
Brief Summary
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In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Helmet to deliver NIV
Helmet (Starmed)
The helmet is a kind of interface similar to a hood to deliver NIV
Total Face to deliver NIV
Total Face mask (Respironics)
The total face mask is the "classical" interface for NIV delivery
Interventions
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Helmet (Starmed)
The helmet is a kind of interface similar to a hood to deliver NIV
Total Face mask (Respironics)
The total face mask is the "classical" interface for NIV delivery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* respiratory rate \> 20 b/min
Exclusion Criteria
* coma
* inability to stand NIV
* lack of informed consent
18 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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dr. Stefano Nava
Chief Respiratory and Critical care
Locations
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Sant'Orsola malpighi Hospital
Bologna, , Italy
Sant'Orsola Malpighi
Bologna, , Italy
Countries
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References
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Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del Forno M, Grassi M, Fasano L, Navalesi P, Nava S. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015 Mar;45(3):691-9. doi: 10.1183/09031936.00053814. Epub 2014 Dec 10.
Other Identifiers
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1222
Identifier Type: -
Identifier Source: org_study_id
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