Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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1 November 2021 |
Main ID: |
NCT03025425 |
Date of registration:
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17/01/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD
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Scientific title:
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Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency |
Date of first enrolment:
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January 2017 |
Target sample size:
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20 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03025425 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Lauri Lehtimäki, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Tampere University Hospital, Allergy centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- a previous diagnosis of COPD
- hospitalized due to acute exacerbation of COPD
- at least moderate dyspnea (NRS = Numeric Rating Scale = 4)
- no acute hypoventilation (pH = 7.35 and PCO2 = 6.0 kPa)
- able to understand the study and to give informed consent
Exclusion Criteria:
- unable to participate and use MPV due to e.g. delirium or lack of co-operation
- acute hypoventilation (pH < 7.35 or PCO2 > 6.0 kPa)
- acute need for ventilatory support
- the cause of the dyspnea can be successfully treated
- unable to give informed consent
- a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been
treated on a long-term basis also at home
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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COPD Exacerbation
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Dyspnea
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Intervention(s)
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Device: Trilogy 100 ® (Philips Respironics)
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Primary Outcome(s)
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Change in dyspnea after initial period of using MPV
[Time Frame: 5-60 min]
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Secondary Outcome(s)
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Proportion of subjects willing to continue on MPV after the intervention
[Time Frame: 24 hours]
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Change in dyspnea after 24 hours of using MPV
[Time Frame: 24 hours]
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Proportion of subjects gaining from MPV
[Time Frame: 24 hours]
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Proportion of subjects having side-effects or not being compliant with MPV
[Time Frame: 24 hours]
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Secondary ID(s)
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R16148_TAYS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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