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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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ClinicalTrials.gov Identifier: NCT02371564
Recruitment Status : Recruiting
First Posted : February 25, 2015
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. corrected minute ventilation [ Time Frame: 1 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lise Piquilloud, MD lise.piquilloud@chuv.ch
Contact: Laure Masson LaMasson@chu-angers.fr

Locations
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France
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         
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02371564     History of Changes
Other Study ID Numbers: CHU-P 2013-25
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Progression
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes