Acute Respiratory FailureOPTI O2NCT01243918
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
A study testing Oxygen therapy delivery systems in people with Acute Respiratory Failure, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal®… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Oxygen therapy delivery systems
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jun 2013
- 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
- Patient hospitalized in the intensive care unit of Nantes University Hospital
- Signed informed consent
- Patient with not hypercapnic acute hypoxemic respiratory failure
- Immunocompetent and immunodeficient patient
Who cannot join
- Age < 18 years
- Pregnancy
- Contra-indication to non invasive ventilation
- Allergy to xylocaine
- Coagulation troubles
- Tracheotomized patient
Show all 10Show fewer
- Urgent indication to intubation
- Hypercapnic acute respiratory failure
- Acute pulmonary edema
- Face or nose malformation
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.
- Conditions
- Acute Respiratory Failure
- Being tested
- Oxygen therapy delivery systems
- Keywords
- Acute respiratory failure, Oxygen therapy delivery systems, Non invasive ventilation, High concentration mask, Hypoxemic pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapy delivery systemsOther
T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2
| Study group | Role | What they receive |
|---|---|---|
| VNI/Optiflow, Immunodeficient patients | Experimental | VNI = non invasive ventilation Receives: Other: Oxygen therapy delivery systems |
| Optiflow/VNI, Immunodeficient patients | Experimental | VNI = non invasive ventilation Receives: Other: Oxygen therapy delivery systems |
| Ospal/Optiflow, Immunocompetent patients | Experimental | Not described Receives: Other: Oxygen therapy delivery systems |
| Optiflow/Ospal, Immunocompetent patients | Experimental | Not described Receives: Other: Oxygen therapy delivery systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcul of the ratio PaO2/FiO2
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2
Measured: one hour after each system used
Secondary outcomes (3)
number of participants with adverse events
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
- number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
- impact on work of breathing: measure of respiratory frequency and blood gas
- measure of positive and expiratory pressure
measure of respiratory frequency and blood gas
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
- number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
- impact on work of breathing: measure of respiratory frequency and blood gas
- measure of positive and expiratory pressure
measure of positive and expiratory pressure
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
- number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
- impact on work of breathing: measure of respiratory frequency and blood gas
- measure of positive and expiratory pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionJun 2013
Why it stopped: Difficulty of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noëlle BRULE, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243918
- Sponsor's protocol ID
- 10/6-D
- Acronym
- OPTI O2
- Status last verified
- Oct 2013
- First submitted
- 18 Nov 2010
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT01243918
- Acronym / sponsor ID
- OPTI O2 / 10/6-D
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute respiratory failure, Oxygen therapy delivery systems, Non invasive ventilation, High concentration mask, Hypoxemic pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Nov 2010 (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.
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VNI/Optiflow, Immunodeficient patients | Experimental | Other: Oxygen therapy delivery systemsVNI = non invasive ventilation |
| Optiflow/VNI, Immunodeficient patients | Experimental | Other: Oxygen therapy delivery systemsVNI = non invasive ventilation |
| Ospal/Optiflow, Immunocompetent patients | Experimental | Other: Oxygen therapy delivery systems |
| Optiflow/Ospal, Immunocompetent patients | Experimental | Other: Oxygen therapy delivery systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient hospitalized in the intensive care unit of Nantes University Hospital
- Signed informed consent
- Patient with not hypercapnic acute hypoxemic respiratory failure
- Immunocompetent and immunodeficient patient
Key exclusion criteria (10 listed)
- Age < 18 years
- Pregnancy
- Contra-indication to non invasive ventilation
- Allergy to xylocaine
- Coagulation troubles
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 |
|---|---|---|
| Oxygen therapy delivery systemsT-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2 | Other | Optiflow/Ospal, Immunocompetent patients, Optiflow/VNI, Immunodeficient patients, Ospal/Optiflow, Immunocompetent patients, VNI/Optiflow, Immunodeficient patients |
Primary outcome
Calcul of the ratio PaO2/FiO2
Time frame: one hour after each system used
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2
3 secondary outcomes
number of participants with adverse events
measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
Results and safety
The study was stopped early (reason given: Difficulty of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
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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.
Noëlle BRULE, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen therapy delivery systems in people with Acute Respiratory Failure, run by Nantes University Hospital 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 4 inclusion and 10 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 7 Oct 2013. 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?
The study was stopped early (reason given: Difficulty of recruitment). 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?
Calcul of the ratio PaO2/FiO2 (time frame: one hour after each system used). 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 7 Oct 2013.