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High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action (Oh BPCO)

Primary Purpose

COPD Exacerbation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High flow humidified oxygen
Standard flow humidified oxygen
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of AngersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High flow humidified oxygen first

Standard oxygen therapy first

Arm Description

High flow humidified oxygen then standard oxygenotherapy with a two-hour non invasive ventilation session in between.

Standard oxygenotherapy then high flow humidified oxygen with a two-hour non invasive ventilation session in between.

Outcomes

Primary Outcome Measures

corrected minute ventilation

Secondary Outcome Measures

Full Information

First Posted
February 19, 2015
Last Updated
March 15, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02371564
Brief Title
High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action
Acronym
Oh BPCO
Official Title
High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High flow humidified oxygen first
Arm Type
Active Comparator
Arm Description
High flow humidified oxygen then standard oxygenotherapy with a two-hour non invasive ventilation session in between.
Arm Title
Standard oxygen therapy first
Arm Type
Active Comparator
Arm Description
Standard oxygenotherapy then high flow humidified oxygen with a two-hour non invasive ventilation session in between.
Intervention Type
Device
Intervention Name(s)
High flow humidified oxygen
Intervention Type
Device
Intervention Name(s)
Standard flow humidified oxygen
Primary Outcome Measure Information:
Title
corrected minute ventilation
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Piquilloud, MD
Email
lise.piquilloud@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Masson
Email
LaMasson@chu-angers.fr
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Mercat, Professor
Phone
(0)2 - 41 - 35 - 38 - 15
Ext
33
Email
AlMercat@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
ALAIN MERCAT, PROF
First Name & Middle Initial & Last Name & Degree
LISE PIQUILLOUD, MD
First Name & Middle Initial & Last Name & Degree
FRANCOIS BELONCLE, MD
First Name & Middle Initial & Last Name & Degree
SATAR MORTAZA, MD
First Name & Middle Initial & Last Name & Degree
ACHILLE KOUATCHET, MD

12. IPD Sharing Statement

Learn more about this trial

High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action

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