HypoxemiaNCT02080208
Which Place for High Flow Oxygen in ICU ?
A study testing Optiflow in people with Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Optiflow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spontaneously breathing patient requiring administration at least 40% oxygen, or,
- Patient under mechanical ventilation, during respiratory weaning.
Who cannot join
- Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.
- Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.
About this study
Official title: Which Place for High Flow Oxygen in Intensive Care Unit ?
Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.
Read the detailed description
The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..
- Conditions
- Hypoxemia
- Being tested
- Optiflow
- Keywords
- hypoxemia, high flow oxygen therapy, respiratory failure
- Medical subject headings
- Hypoxia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiflowDevice
patients receive oxygen via high flow oxygen therapy during 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| High Flow Oxygen | Experimental | Patients receiving oxygen via high flow oxygen therapy (Optiflow) Receives: Device: Optiflow |
| Conventionnal | No intervention | patients receiving oxygen via conventional way (low flow) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Oxygenation criteria
Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)
Measured: 20 minutes
Secondary outcomes (1)
Change from baseline in Ventilation criteria
respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bialais, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Emilie Bialais, PhD Student, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080208
- Sponsor's protocol ID
- OptSCM
- Status last verified
- Jan 2016
- First submitted
- 9 Jan 2014
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Place for High Flow Oxygen in Intensive Care Unit ?
- ClinicalTrials.gov ID
- NCT02080208
- Acronym / sponsor ID
- OptSCM
- Conditions
- Hypoxemia
- Keywords
- hypoxemia, high flow oxygen therapy, respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Mar 2014 (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.
Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.
Detailed description
The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Oxygen | Experimental | Device: OptiflowPatients receiving oxygen via high flow oxygen therapy (Optiflow) |
| Conventionnal | No intervention | –patients receiving oxygen via conventional way (low flow) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Spontaneously breathing patient requiring administration at least 40% oxygen, or,
- Patient under mechanical ventilation, during respiratory weaning.
Key exclusion criteria (2 listed)
- Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.
- Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.
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 |
|---|---|---|
| Optiflowpatients receive oxygen via high flow oxygen therapy during 20 minutes | Device | High Flow Oxygen |
Primary outcome
Change from baseline in Oxygenation criteria
Time frame: 20 minutes
Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)
1 secondary outcome
Change from baseline in Ventilation criteria
Time frame: 20 minutes
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 1 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Emilie Bialais, PhD Student principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow in people with Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 2 inclusion and 2 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in Oxygenation criteria (time frame: 20 minutes). 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 1 Feb 2016.