COPD ExacerbationOh BPCONCT02371564
High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action
A study testing High flow humidified oxygen and Standard flow humidified oxygen in people with COPD Exacerbation, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- High flow humidified oxygen and Standard flow humidified oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lise Piquilloud, MD contact
Laure Masson contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, 49933
Alain Mercat, Professor, (0)2 - 41 - 35 - 38 - 15 ext. 33, AlMercat@chu-angers.fr
ALAIN MERCAT, PROF
About this study
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.
- Conditions
- COPD Exacerbation
- Being tested
- High flow humidified oxygen, Standard flow humidified oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow humidified oxygenDevice
Standard flow humidified oxygenDevice
| Study group | Role | What they receive |
|---|---|---|
| High flow humidified oxygen first | Active comparator | High flow humidified oxygen then standard oxygenotherapy with a two-hour non invasive ventilation session in between. Receives: Device: High flow humidified oxygen |
| Standard oxygen therapy first | Active comparator | Standard oxygenotherapy then high flow humidified oxygen with a two-hour non invasive ventilation session in between. Receives: Device: Standard flow humidified oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
corrected minute ventilation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371564
- Sponsor's protocol ID
- CHU-P 2013-25
- Acronym
- Oh BPCO
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2015
- Last updated
- 19 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action
- ClinicalTrials.gov ID
- NCT02371564
- Acronym / sponsor ID
- Oh BPCO / CHU-P 2013-25
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2015
- Primary completion
- Dec 2019 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow humidified oxygen first | Active comparator | Device: High flow humidified oxygenHigh flow humidified oxygen then standard oxygenotherapy with a two-hour non invasive ventilation session in between. |
| Standard oxygen therapy first | Active comparator | Device: Standard flow humidified oxygenStandard oxygenotherapy then high flow humidified oxygen with a two-hour non invasive ventilation session in between. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow humidified oxygen | Device | High flow humidified oxygen first |
| Standard flow humidified oxygen | Device | Standard oxygen therapy first |
Primary outcome
corrected minute ventilation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Piquilloud, MD contact
Laure Masson contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow humidified oxygen and Standard flow humidified oxygen in people with COPD Exacerbation, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Piquilloud, MD (lise.piquilloud@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corrected minute ventilation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.