Acute Respiratory FailurePhase 3RESPIR-OHNCT02424773
Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
A Phase 3 study testing High Flow Nasal Canula (HFNC), Venturi mask and Oxygen in people with Acute Respiratory Failure and Immunocompromised Host, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Immunocompromised Host, High Flow Oxygen Cannula
- What is being tested?
- High Flow Nasal Canula (HFNC), Venturi mask and Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Apr 2015
- Phase
- Phase 3
- 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 over 18 years.
- Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea >30/min or dyspnea at rest).
- Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection.
Who cannot join
- Hypercapnia (above 47 mmHg)
- Chronic respiratory failure
- Previous mechanical ventilation in the days before admission
- Need of immediate NIV or intubation
- Refusal
- Pregnancy
About this study
In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.
- Being tested
- High Flow Nasal Canula (HFNC), Venturi mask, Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Canula (HFNC)Device
Venturi maskDevice
OxygenDrug
| Study group | Role | What they receive |
|---|---|---|
| Venturi group | Active comparator | Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%. Receives: Device: Venturi mask; Drug: Oxygen |
| HFNC group | Experimental | HFNC group : Oxygen is delivered using HFNC. HFNC is started with FIO2 =1 and modified to maintain SpO2 over 94%, flow is settled at 40-50l/min. Receives: Device: High Flow Nasal Canula (HFNC); Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation failure
Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period
Measured: 2 hours
Secondary outcomes (6)
comfort (0-10 Visual analog Scale)
0-10 Visual analog Scale
Measured: 1 hour
comfort (0-10 Visual analog Scale)
0-10 Visual analog Scale
Measured: 2 hours
dyspnea (0-10 Visual analog Scale)
0-10 Visual analog Scale
Measured: 1 hour
dyspnea (0-10 Visual analog Scale)
0-10 Visual analog Scale
Measured: 2 hour
thirst (0-10 Visual analog Scale)
0-10 Visual analog Scale
Measured: 1 hour
thirst (0-10 Visual analog Scale)
0-10 Visual analog Scale
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionApr 2015
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 Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie COURTIAL DESTEMBERT, Study director, DRCD APHP Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424773
- Sponsor's protocol ID
- K101201
- Acronym
- RESPIR-OH
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
PubMed 26521922
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
- ClinicalTrials.gov ID
- NCT02424773
- Acronym / sponsor ID
- RESPIR-OH / K101201
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Apr 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.
In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venturi group | Active comparator | Device: Venturi mask, Drug: OxygenVenturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%. |
| HFNC group | Experimental | Device: High Flow Nasal Canula (HFNC), Drug: OxygenHFNC group : Oxygen is delivered using HFNC. HFNC is started with FIO2 =1 and modified to maintain SpO2 over 94%, flow is settled at 40-50l/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years.
- Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea >30/min or dyspnea at rest).
- Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection.
Key exclusion criteria (6 listed)
- Hypercapnia (above 47 mmHg)
- Chronic respiratory failure
- Previous mechanical ventilation in the days before admission
- Need of immediate NIV or intubation
- Refusal
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 |
|---|---|---|
| High Flow Nasal Canula (HFNC) | Device | HFNC group |
| Venturi mask | Device | Venturi group |
| Oxygen | Drug | HFNC group, Venturi group |
Primary outcome
Oxygenation failure
Time frame: 2 hours
Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period
6 secondary outcomes
comfort (0-10 Visual analog Scale)
Time frame: 1 hour
comfort (0-10 Visual analog Scale)
Time frame: 2 hours
dyspnea (0-10 Visual analog Scale)
Time frame: 1 hour
dyspnea (0-10 Visual analog Scale)
Time frame: 2 hour
thirst (0-10 Visual analog Scale)
Time frame: 1 hour
thirst (0-10 Visual analog Scale)
Time frame: 2 hour
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 18 Apr 2016.
- Results publication: PubMed 26521922Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
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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.
Sophie COURTIAL DESTEMBERT study director
DRCD APHP Paris
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High Flow Nasal Canula (HFNC), Venturi mask and Oxygen in people with Acute Respiratory Failure and Immunocompromised Host, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 6 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 18 Apr 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Oxygenation failure (time frame: 2 hours). 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 NCT02424773, 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 18 Apr 2016.