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
16 participants
INTERVENTIONAL
2021-07-28
2022-03-17
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
BASIC_SCIENCE
NONE
Study Groups
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Investigation Mask
Bi Level CPAP Mask
Investigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Comparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Comparator Mask
Bi Level CPAP Mask
Investigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Comparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Interventions
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Investigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Comparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Eligibility Criteria
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Inclusion Criteria
* PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure
* Oxygen saturation measured by pulse oximetry (SpO2) ≥85%
* Fits the study mask
* Can tolerate the therapy
Exclusion Criteria
* Body mass index \>35
* Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea
* Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement
18 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Alex Semprini
Role: PRINCIPAL_INVESTIGATOR
Medical Research Institute of New Zealand
Locations
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Medical Research Institute New Zealand
Wellington, , New Zealand
Countries
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Other Identifiers
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CIA293
Identifier Type: -
Identifier Source: org_study_id
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