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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02371564 |
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Date of registration:
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19/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action
Oh BPCO |
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Scientific title:
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High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02371564 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover 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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France
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Contacts
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Name:
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Alain Mercat, Professor |
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Address:
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Telephone:
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(0)2 - 41 - 35 - 38 - 15 |
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Email:
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AlMercat@chu-angers.fr |
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Affiliation:
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Name:
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Lise Piquilloud, MD |
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Address:
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Telephone:
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Email:
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lise.piquilloud@chuv.ch |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- COPD patients suffering from acute hypercapnic respiratory failure (PaCO2 > 50 mmHg)
due to COPD exacerbation and requiring intermittent NIV treatment can be included in
the study provided they do not require immediate intubation.
Exclusion Criteria:
- Patients younger than 18 years old
- Inability to give informed consent or denied informed consent
- Severe acute respiratory failure requiring immediate intubation defined as respiratory
rate > 40/minute, severe hypoxemia with PaO2/FIO2 ratio < 150 mmHg despite high FIO2,
severe respiratory acidosis with pH< 7.2, altered mental status)
- Very intensive NIV treatment required defined as an impossibility to stop NIV
treatment during more than one hour.
- Severe hypoxemia requiring more than 4l/minute of conventional oxygenotherapy between
NIV treatments
- Poor short term prognosis (defined by the clinician in charge as a high risk of death
during the next 7 days) or ongoing palliative treatment.
- Patients with "Do not resuscitate" order already established
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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Intervention(s)
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Device: Standard flow humidified oxygen
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Device: High flow humidified oxygen
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Primary Outcome(s)
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corrected minute ventilation
[Time Frame: 1 hour]
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Secondary ID(s)
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CHU-P 2013-25
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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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