Respiratory FailureNCT01056952
Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure (OPTIFLOW)
A study testing O2stand, CPAP and Optiflow in people with Respiratory Failure, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of inspiratory muscle effort, gas exchange, comfort and dyspnea Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- O2stand, CPAP and Optiflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jan 2012
- 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
- Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio of 300 mm Hg or less after breathing oxygen
- The presence of lung infiltrates on a posteroanterior chest radiograph
Who cannot join
- Face or cranial trauma or surgery
- Patients younger than 18 years
- History of COPD
- Acute respiratory acidosis (defined as a pH <7.30 and a PaCO2 >50 mm Hg)
- Hemodynamic instability with arterial pressure < 90mmHg
- Respiratory instability with PaO2/FiO2<100mmHg
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- ventricular arrhythmias
- Excess respiratory secretions.
- Upper gastrointestinal bleeding
- Recent gastric or oesophageal surgery
- Tracheostomy or other airways disorders
- Pneumothorax
- Contraindication of gastric probe insertion
- Impossibility to insert the oesophageal probe
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure
The aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of inspiratory muscle effort, gas exchange, comfort and dyspnea
Read the detailed description
The administration of a known concentration of oxygen is an important part of routine care of the patient admitted in intensive care unit for acute hypoxemic respiratory failure. A new high flow oxygen delivery system (Fisher and Paykel Health care) has been developed (Optiflow). The system used a heated humidifier and heated breathing circuit via a nasal interface. High flow nasal therapy (Optiflow) is associated with the generation of significant positive airway pressure in healthy volunteers. Positive expiratory pressure may have a number of benefits in respiratory failure which include improved ventilation/perfusion matching with improved oxygenation, reduced airways resistance and reduced work of breathing. Moreover high flow nasal therapy may improve oxygen administration by decreasing oxygen dilution, decreasing death space and using high levels of humidification
- Conditions
- Respiratory Failure
- Being tested
- O2stand, CPAP, Optiflow
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2standProcedure or surgery
Standard low flow oxygen therapy (O2stand). The patients will receive oxygen delivered through a face mask. The FiO2 will be adjusted in order to obtain a SaO2 > 90%. The FiO2 will be determined by a portable oxygen analyzer (MiniOX I; Mine Safety Appliances Co, Pittsburgh, Pa)
CPAPProcedure or surgery
- Continuous positive airway pressure (CPAP). CPAP will be set at 7.5 cmH2O. Airway humidification will be achieved by using a heated humidifier (MR640; Fisher \& Paykel, Auckland, NZ). The FiO2 will be adjusted in order to obtain a SaO2 > 90%. A facial mask composed of a transparent mask and a soft inflatable will be used
OptiflowProcedure or surgery
High flow oxygen nasal therapy (Optiflow). The flow will be set at 40l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SaO2 > 90%
| Study group | Role | What they receive |
|---|---|---|
| Optiflow then CPAP | Experimental | Standard low flow oxygen therapy then High flow oxygen nasal therapy (Optiflow)then Continuous positive airway pressure (CPAP) Receives: Procedure: O2stand; Procedure: CPAP; Procedure: Optiflow |
| CPAP then Optiflow | Experimental | Standard low flow oxygen therapy then Continuous positive airway pressure (CPAP)then High flow oxygen nasal therapy (Optiflow) Receives: Procedure: O2stand; Procedure: CPAP; Procedure: Optiflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)
Measured: Every 30 minutes for 90 minutes
Secondary outcomes (3)
Gas exchange :PaO2/FiO2 ratio
Measured: Every 30 minutes for 90 minutes
Comfort assessed using a five-item semi quantitative scale
Measured: Every 30 minutes for 90 minutes
Dyspnea assessed using a visual analogic scale
Measured: Every 30 minutes for 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VARGAS, MD, Principal investigator, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056952
- Sponsor's protocol ID
- CHUBX 2009/15
- Status last verified
- Jun 2012
- First submitted
- 18 Jan 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.
PubMed 25944940
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01056952
- Acronym / sponsor ID
- CHUBX 2009/15
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Jan 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 aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of inspiratory muscle effort, gas exchange, comfort and dyspnea
Detailed description
The administration of a known concentration of oxygen is an important part of routine care of the patient admitted in intensive care unit for acute hypoxemic respiratory failure. A new high flow oxygen delivery system (Fisher and Paykel Health care) has been developed (Optiflow). The system used a heated humidifier and heated breathing circuit via a nasal interface. High flow nasal therapy (Optiflow) is associated with the generation of significant positive airway pressure in healthy volunteers. Positive expiratory pressure may have a number of benefits in respiratory failure which include improved ventilation/perfusion matching with improved oxygenation, reduced airways resistance and reduced work of breathing. Moreover high flow nasal therapy may improve oxygen administration by decreasing oxygen dilution, decreasing death space and using high levels of humidification
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow then CPAP | Experimental | Procedure: O2stand, Procedure: CPAP, Procedure: OptiflowStandard low flow oxygen therapy then High flow oxygen nasal therapy (Optiflow)then Continuous positive airway pressure (CPAP) |
| CPAP then Optiflow | Experimental | Procedure: O2stand, Procedure: CPAP, Procedure: OptiflowStandard low flow oxygen therapy then Continuous positive airway pressure (CPAP)then High flow oxygen nasal therapy (Optiflow) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio of 300 mm Hg or less after breathing oxygen
- The presence of lung infiltrates on a posteroanterior chest radiograph
Key exclusion criteria (14 listed)
- Face or cranial trauma or surgery
- Patients younger than 18 years
- History of COPD
- Acute respiratory acidosis (defined as a pH <7.30 and a PaCO2 >50 mm Hg)
- Hemodynamic instability with arterial pressure < 90mmHg
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 |
|---|---|---|
| O2standStandard low flow oxygen therapy (O2stand). The patients will receive oxygen delivered through a face mask. The FiO2 will be adjusted in order to obtain a SaO2 > 90%. The FiO2 will be determined by a portable oxygen analyzer (MiniOX I; Mine Safety Appliances Co, Pittsburgh, Pa) | Procedure or surgery | CPAP then Optiflow, Optiflow then CPAP |
| CPAPo Continuous positive airway pressure (CPAP). CPAP will be set at 7.5 cmH2O. Airway humidification will be achieved by using a heated humidifier (MR640; Fisher \& Paykel, Auckland, NZ). The FiO2 will be adjusted in order to obtain a SaO2 > 90%. A facial mask composed of a transparent mask and a soft inflatable will be used | Procedure or surgery | CPAP then Optiflow, Optiflow then CPAP |
| OptiflowHigh flow oxygen nasal therapy (Optiflow). The flow will be set at 40l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SaO2 > 90% | Procedure or surgery | CPAP then Optiflow, Optiflow then CPAP |
Primary outcome
Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)
Time frame: Every 30 minutes for 90 minutes
3 secondary outcomes
Gas exchange :PaO2/FiO2 ratio
Time frame: Every 30 minutes for 90 minutes
Comfort assessed using a five-item semi quantitative scale
Time frame: Every 30 minutes for 90 minutes
Dyspnea assessed using a visual analogic scale
Time frame: Every 30 minutes for 90 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 14 Jun 2012.
- Derived from this study: PubMed 25944940Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.
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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.
Frédéric VARGAS, MD principal investigator
University Hospital, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2stand, CPAP and Optiflow in people with Respiratory Failure, run by University Hospital, Bordeaux 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 2 inclusion and 14 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 14 Jun 2012. 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?
Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes) (time frame: Every 30 minutes for 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056952, which also lists 1 linked publication.
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 2012.