Chronic Obstructive Pulmonary Disease With Acute Exacerbation, UnspecifiedOXYSETNCT02563314
Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease
A study testing Non-invasive mechanical ventilation - Normoxia in people with Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
- What is being tested?
- Non-invasive mechanical ventilation - Normoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Mar 2017to 24 Sep 2018
- 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
- Age > 18 years
- Acute hypercapnic COPD exacerbation
- Respiratory acidosis
- Intensive care unit admission
- Non-Invasive mechanical ventilation for less than 24 hours
- Patients or proxy consent
- Patients affiliated with the General Social Security Health System
Who cannot join
- Pregnancy
- Sickle cells disease
- Acute coronary syndrome
- Restrictive respiratory disease
- Stage 4 or 5 chronic kidney disease
- COPD exacerbation following a first episode of conventional mechanical ventilation
- Contraindications to non-invasive ventilation
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de CLERMONT-FERRAND
Clermont-Ferrand, 63000
CHu de GRENOBLE
Grenoble, 38000
CHU de la Pitié-Salpêtrière
Paris, 75013
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
About this study
Official title: Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.
- Being tested
- Non-invasive mechanical ventilation - Normoxia, Non-invasive mechanical ventilation - Controlled hypoxemia
- Keywords
- Noninvasive Ventilation, Pulmonary Disease, Chronic Obstructive, Renal Doppler, Oxygen, Hypercapnia
- Medical subject headings
- Lung Diseases, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive mechanical ventilation - NormoxiaDevice
Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)
Non-invasive mechanical ventilation - Controlled hypoxemiaDevice
Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Device: Non-invasive mechanical ventilation - Normoxia |
| control | Other | Not described Receives: Device: Non-invasive mechanical ventilation - Controlled hypoxemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary output (ml)
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours
Secondary outcomes (12)
Changes in CO2 levels
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration)
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72 hours
Serum creatinine
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
Renal resistive index
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
Pulmonary arterial pressure
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
Semiquantitative assessment of dyspnea (visual likert scale)
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
Semiquantitative assessment of comfort (visual likert scale)
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
Fluid balance
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
SOFA (Sequential Organ Failure Assessment) score
First 24 hours of non-invasive mechanical ventilation
Measured: 24 hours, 48 hours, 72hours
Mortality
First 24 hours of non-invasive mechanical ventilation
Measured: up to day 28
Number of patients requiring mechanical ventilation
Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Measured: up to day 28
days alive without mechanical ventilation
Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start22 Mar 2017
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Why it stopped: departure of the coordinating investigator from another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease With Acute Exacerbation, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael DARMON, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563314
- Sponsor's protocol ID
- 1408025
- Other IDs
- ANSM
- Acronym
- OXYSET
- Status last verified
- Jun 2019
- First submitted
- 24 Sep 2015
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02563314
- Acronym / sponsor ID
- OXYSET / 1408025
- Keywords
- Noninvasive Ventilation, Pulmonary Disease, Chronic Obstructive, Renal Doppler, Oxygen, Hypercapnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of the coordinating investigator from another institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 30 Sep 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.
Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Non-invasive mechanical ventilation - Normoxia |
| control | Other | Device: Non-invasive mechanical ventilation - Controlled hypoxemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Acute hypercapnic COPD exacerbation
- Respiratory acidosis
- Intensive care unit admission
- Non-Invasive mechanical ventilation for less than 24 hours
Key exclusion criteria (7 listed)
- Pregnancy
- Sickle cells disease
- Acute coronary syndrome
- Restrictive respiratory disease
- Stage 4 or 5 chronic kidney disease
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 |
|---|---|---|
| Non-invasive mechanical ventilation - NormoxiaMaintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%) | Device | intervention |
| Non-invasive mechanical ventilation - Controlled hypoxemiaMaintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%) | Device | control |
Primary outcome
urinary output (ml)
Time frame: 24 hours
First 24 hours of non-invasive mechanical ventilation
12 secondary outcomes
Changes in CO2 levels
Time frame: 24 hours, 48 hours, 72hours
respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration)
Time frame: 24 hours, 48 hours, 72 hours
Serum creatinine
Time frame: 24 hours, 48 hours, 72hours
Renal resistive index
Time frame: 24 hours, 48 hours, 72hours
Pulmonary arterial pressure
Time frame: 24 hours, 48 hours, 72hours
Semiquantitative assessment of dyspnea (visual likert scale)
Time frame: 24 hours, 48 hours, 72hours
Semiquantitative assessment of comfort (visual likert scale)
Time frame: 24 hours, 48 hours, 72hours
Fluid balance
Time frame: 24 hours, 48 hours, 72hours
SOFA (Sequential Organ Failure Assessment) score
Time frame: 24 hours, 48 hours, 72hours
Mortality
Time frame: up to day 28
Number of patients requiring mechanical ventilation
Time frame: up to day 28
days alive without mechanical ventilation
Time frame: up to day 28
Results and safety
The study was stopped early (reason given: departure of the coordinating investigator from another institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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.
Michael DARMON, MD PhD principal investigator
CHU de SAINT-ETIENNE
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive mechanical ventilation - Normoxia in people with Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites 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 7 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: stopped early, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: departure of the coordinating investigator from another institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary output (ml) (time frame: 24 hours). 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 14 Jun 2019.