High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action (Oh BPCO)
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|ClinicalTrials.gov Identifier: NCT02371564|
Recruitment Status : Recruiting
First Posted : February 25, 2015
Last Update Posted : March 19, 2019
Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor outcome, especially when intubation is required, thus underlining the importance of optimizing non-invasive ventilatory support to avoid intubation. Practically, because of treatment intolerance, non-invasive ventilation (NIV) cannot be administered 24-hour a day for a long period of time and alternative solutions must be found to deliver oxygen as efficiently as possible to allow NIV interruptions. High flow humidified oxygen therapy (HFHO) consists of delivering a high-flow (15-60 L/minute) heated air-oxygen mixture (FIO2 21-100%) through a dedicated nasal cannula and can be interesting in this context. This well tolerated technique improves oxygenation and decreases respiratory rate and dyspnea in patients suffering from acute hypoxemic respiratory failure. In chronic COPD patients, using HFHO can decrease respiratory rate and PaCO2. In COPD exacerbation, using HFHO can conceptually be interesting. First, the high air-oxygen flow delivered well matches the patient's inspiratory demand and should decrease the work of breathing. Second, as during HFHO a high flow is continuously delivered in the airways, a wash-out of the anatomical dead space should occur and CO2 clearance should be enhanced. Despite this strong physiological rational for the use of HFHO in patients suffering from COPD exacerbation, the effects of using HFHO instead of conventional oxygenotherapy in combination with non-invasive ventilation (NIV) in this context has never been explored.
The main objective of the study is to explore the effects of using HFHO in combination with NIV in acute COPD exacerbation and to assess the underlying mechanisms of action.
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Device: High flow humidified oxygen Device: Standard flow humidified oxygen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2019|
Active Comparator: High flow humidified oxygen first
High flow humidified oxygen then standard oxygenotherapy with a two-hour non invasive ventilation session in between.
Device: High flow humidified oxygen
Active Comparator: Standard oxygen therapy first
Standard oxygenotherapy then high flow humidified oxygen with a two-hour non invasive ventilation session in between.
Device: Standard flow humidified oxygen
- corrected minute ventilation [ Time Frame: 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371564
|Contact: Lise Piquilloud, MDemail@example.com|
|Contact: Laure Masson||LaMasson@chu-angers.fr|
|University Hospital of Angers||Recruiting|
|Angers, France, 49933|
|Contact: Alain Mercat, Professor (0)2 - 41 - 35 - 38 - 15 ext 33 AlMercat@chu-angers.fr|
|Principal Investigator: ALAIN MERCAT, PROF|
|Sub-Investigator: LISE PIQUILLOUD, MD|
|Sub-Investigator: FRANCOIS BELONCLE, MD|
|Sub-Investigator: SATAR MORTAZA, MD|
|Sub-Investigator: ACHILLE KOUATCHET, MD|