Hypoxemic Acute Respiratory FailureOptiflowNCT01617252
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
A study testing Optiflow / Facial mask in people with Hypoxemic 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 gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Acute Respiratory Failure
- What is being tested?
- Optiflow / Facial mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Apr 2015
- 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 with indication of coronary artery bypass
- Absence of preoperative respiratory failure
- Hypoxia after extubation defined as SpO2 < 96% with Venturi mask 50% 8L/min
- Age > 18 years
- Signed informed consent
Who cannot join
- Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
- Hemodynamic instability, low flow rate
- Pneumothorax or hemothorax
- Bleeding major, ischemic signs
- Ventricular arrhythmia
- Respiratory failure
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- Non controlled hyperalgia
- Alteration of mental status
- Cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery
- Pregnancy
- Major under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
- Conditions
- Hypoxemic Acute Respiratory Failure
- Being tested
- Optiflow / Facial mask
- Keywords
- Cardiac surgery, Acute respiratory failure, High flow oxygen therapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow / Facial maskDevice
J0: randomization (Optiflow® or facial mask), lung X-ray, kinesiotherapy H0 : clinical examination, blood gas, respiratory frequency H1 : clinical examination, blood gas, respiratory frequency H6 : clinical examination, blood gas J1: clinical examination, blood gas, respiratory frequency, lung X-ray, diaphragmatic echography, kinesiotherapy J2: clinical examination, blood gas, lung X-ray, kinesiotherapy Follow-up (until withdrawal of Optiflow or facial mask): clinical examination, blood gas, lung X-ray, kinesiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Optiflow | Experimental | Not described Receives: Device: Optiflow / Facial mask |
| Facial mask | Experimental | Not described Receives: Device: Optiflow / Facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of PaO2/FiO2 ratio
The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
Measured: One hour and 24 hours
Secondary outcomes (5)
Scale of satisfaction completed by the patient
To evaluate the tolerance of high flow oxygen therapy: satisfaction scale
Measured: at withdrawal of oxygen system
Measure of pH, SatO2, PaO2, FiO2
To evaluate hypoxia duration
Measured: 2 days
Number of days of hospitalization
To evaluate the duration of hospitalization with the medical device
Measured: at day 28
Measure of PCO2 and respiratory frequency
To evaluate PCO2 and respiratory frequency at H+1 and J1
Measured: One day
Possibility of patient transfer in conventional service
To evaluate the reception in post reanimation if transfer under oxygen therapy
Measured: at day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617252
- Sponsor's protocol ID
- BRD/10/09-H
- Acronym
- Optiflow
- Status last verified
- Oct 2018
- First submitted
- 8 Jun 2012
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01617252
- Acronym / sponsor ID
- Optiflow / BRD/10/09-H
- Conditions
- Hypoxemic Acute Respiratory Failure
- Keywords
- Cardiac surgery, Acute respiratory failure, High flow oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Jun 2012 (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 gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow | Experimental | Device: Optiflow / Facial mask |
| Facial mask | Experimental | Device: Optiflow / Facial mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with indication of coronary artery bypass
- Absence of preoperative respiratory failure
- Hypoxia after extubation defined as SpO2 < 96% with Venturi mask 50% 8L/min
- Age > 18 years
- Signed informed consent
Key exclusion criteria (11 listed)
- Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
- Hemodynamic instability, low flow rate
- Pneumothorax or hemothorax
- Bleeding major, ischemic signs
- Ventricular arrhythmia
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 |
|---|---|---|
| Optiflow / Facial maskJ0: randomization (Optiflow® or facial mask), lung X-ray, kinesiotherapy H0 : clinical examination, blood gas, respiratory frequency H1 : clinical examination, blood gas, respiratory frequency H6 : clinical examination, blood gas J1: clinical examination, blood gas, respiratory frequency, lung X-ray, diaphragmatic echography, kinesiotherapy J2: clinical examination, blood gas, lung X-ray, kinesiotherapy Follow-up (until withdrawal of Optiflow or facial mask): clinical examination, blood gas, lung X-ray, kinesiotherapy | Device | Facial mask, Optiflow |
Primary outcome
Measure of PaO2/FiO2 ratio
Time frame: One hour and 24 hours
The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
5 secondary outcomes
Scale of satisfaction completed by the patient
Time frame: at withdrawal of oxygen system
Measure of pH, SatO2, PaO2, FiO2
Time frame: 2 days
Number of days of hospitalization
Time frame: at day 28
Measure of PCO2 and respiratory frequency
Time frame: One day
Possibility of patient transfer in conventional service
Time frame: at day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow / Facial mask in people with Hypoxemic 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 4 Oct 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of PaO2/FiO2 ratio (time frame: One hour and 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 4 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.