Sickle Cell DiseaseOSONENCT03976180
High-flow Oxygen for Vaso-occlusive Pain Crisis
A study testing Stadard low-flow oxygen, HFNO with low FiO2 (21%-30%) and HFNO with intermediate FiO2 (50%) in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive pain crisis (VOC), which may evolve to acute chest syndrome (ACS), the most common cause of death among adult patients with SCD. Currently, there is no safe and effective treatment to abort VOC or prevent secondary ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Stadard low-flow oxygen, HFNO with low FiO2 (21%-30%) and HFNO with intermediate FiO2 (50%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 27 Nov 2025
- 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
- Age ≥ 18 years;
- Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+);
- VOC as defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, that requires opioids and is not attributable to other causes;
- Intermediate-to-high risk for secondary ACS derived from the PRESEV score (Bartolucci et al, EBioMedicine 2016) as follows: a reticulocyte count >216 G/L OR at least two of the followings : i) spine and/or pelvis CPS >1; ii) leucocyte count >11G/L; iii) hemoglobin ≤ 9 g/dL; in case of long-term treatment by hydroxyurea, only one of the above mentioned criteria will be needed, given its effects on hemoglobin, leucocyte and reticulocytes counts;
- Informed consent;
- Patient affiliated to social security
Who cannot join
- The presence at inclusion of a primary ACS. Primary ACS is defined by the combination at time of randomization of a clinical sign [chest pain or auscultatory abnormality (crepitants and/or bronchial breathing)] with a new pulmonary infiltrate (on chest film, thoracic scan, or lung ultrasound);
- VOC with need of parenteral opioids lasting longer than 72 hours at time of inclusion;
- Known pregnancy or current lactation; Women of child bearing potential will be tested for pregnancy before inclusion;
- Known cerebral vasculopathy or past medical history of stroke, due to Moya Moya or persisting visible macrovessel stenosis/occlusion;
- Known ischemic heart disease or typical chest angina;
- Patient who is currently enrolled in other investigational drug study;
Show all 9Show fewer
- Known legal incapacity,
- Prisoners or subjects who are involuntarily incarcerated
- Anatomical factors precluding placement of a nasal cannula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Prospective, Randomized, Multi-arm, Multi-stage Clinical Trial of High-flow Oxygen for Vaso-occlusive Pain Crisis in Adult Patients With Sickle Cell Disease;
Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive pain crisis (VOC), which may evolve to acute chest syndrome (ACS), the most common cause of death among adult patients with SCD. Currently, there is no safe and effective treatment to abort VOC or prevent secondary ACS. Management of VOC mostly involve a symptomatic approach including hydration, analgesics, transfusion, and incentive spirometry, which was investigated in a very limited number of patients (<30).
The polymerisation of HbS is one major feature in the pathogenesis of vaso-occlusion. Among factors determining the rate and extent of HbS polymer formation, the hypoxic stimulus is one of the most potent and readily alterable. Current guidelines recommend oxygen therapy in patients with VOC in order to maintain a target oxygen saturation of 95%. Low-flow nasal oxygen (LFNO) is routinely used to achieve this normoxia approach, particularly in patients at risk of secondary ACS because they may experience acute desaturation. In contrast, various case series suggest a potential beneficial role of intensified oxygen therapy targeting hyperoxia for the management of VOC, particularly with the use of hyperbaric oxygen, but the latter is difficult to implement in routine clinical practice.
Read more
A recent high-flow nasal oxygen (HFNO) technology allows the delivery of humidified gas at high fraction of inspired oxygen (FiO2) through nasal cannula. The FiO2 can be adjusted up to 100% (allowing hyperoxia that may reverse sickling) and the flow can be increased up to 60 L/min (which generates positive airway pressure and dead space flushing, that may prevent evolution of VOC towards ACS by alleviating atelectasis and opioid-induced hypercapnia). In patients with acute respiratory failure, HFNO has been shown to improve patient's comfort, oxygenation, and survival as compared to standard oxygen or non-invasive ventilation.
The aim of the present study is to test the efficacy and safety of HFNO for the management of VOC and prevention of secondary ACS. The investigators will use a multi-arm multi-stage (MAMS) design to achieve these goals. HFNO will be delivered through AIRVO 2 (Fisher and Paykel Healthcare, New Zealand), a device that incorporates a turbine allowing its use in hospital wards.
- Conditions
- Sickle Cell Disease
- Being tested
- Stadard low-flow oxygen, HFNO with low FiO2 (21%-30%), HFNO with intermediate FiO2 (50%), HFNO with high FiO2 (100%)
- Keywords
- Sickle Cell Disease, vaso-occlusive pain crisis, HFNO, ACS
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stadard low-flow oxygenDevice
Also called Control group
In the control group, standard low-flow oxygen will be delivered via nasal prongs (LFNO), up to hospital discharge or secondary ACS onset, in order to achieve normoxia (target pulse oxymetry saturation of 95%). This strategy is in accordance with current recommendations and usual care
HFNO with low FiO2 (21%-30%)Device
Also called Intervention group
HFNO with low FiO2 (21%-30%) targeting normoxia: to test the effect of improved pulmonary function
HFNO with intermediate FiO2 (50%)Device
Also called Intervention group
In this group, FiO2 will be set at 50% during the first 24 hours of intervention to target moderate hyperoxia, then reduced to 21-3025% during the following 48 hours to target normoxia
HFNO with high FiO2 (100%)Device
Also called Intervention group
In this group, FiO2 will be set at 100% during the first 24 hours of intervention to target intense hyperoxia, then reduced to 21-3025% during the following 48 hours to target normoxia
| Study group | Role | What they receive |
|---|---|---|
| standard low-flow oxygen | Active comparator | In the control group, standard low-flow oxygen will be delivered via nasal prongs (LFNO), up to hospital discharge or secondary ACS onset, in order to achieve normoxia (target pulse oxymetry saturation of 95%). This strategy is in accordance with current recommendations and usual care; Receives: Device: Stadard low-flow oxygen |
| HFNO with low FiO2 (21%-30%) | Experimental | HFNO with low FiO2 (21%-30%) targeting normoxia: to test the effect of improved pulmonary function; Receives: Device: HFNO with low FiO2 (21%-30%) |
| HFNO with intermediate FiO2 (50%) | Experimental | HFNO with intermediate FiO2 (50%): to test the combined effect of improved pulmonary function and moderate hyperoxia; in this group, FiO2 will be set at 50% during the first 24 hours of intervention to target moderate hyperoxia, then reduced to 21-30% during the following 48 hours to target normoxia Receives: Device: HFNO with intermediate FiO2 (50%) |
| HFNO with high FiO2 (100%) | Experimental | HFNO with high FiO2 (100%): to test the combined effect of improved pulmonary function and intense hyperoxia; in this group, FiO2 will be set at 100% during the first 24 hours of intervention to target intense hyperoxia, then reduced to 21-30% during the following 48 hours to target normoxia Receives: Device: HFNO with high FiO2 (100%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cardiac and neurologic related events (Pilot Stage)
This endpoint will be assessed at the end of the "pilot stage" and throughout the entire study for cumulative safety information. Research arms will only continue to recruitment in the next stage if they have been shown to be both safe (<5 cardiac or neurologic related events, in the arm during the pilot phase as defined by one of the following: acute coronary syndrome, acute ischemic stroke, or seizure) and feasible (<8 definitive discontinuations before day-2 due to patient's intolerance), although patient data from all patients and all stages will be included in the final analyses.
Measured: At the end end of the "pilot stage" and up to 28 days
Rate of vaso-occlusive pain crisis (VOC) resolution without complication (Activity stage)
VOC will be considered terminated when at least 3 of the following 4 criteria are met at two consecutive assessments: i) absence of fever for 8 hours; ii) absence of pain progression and no requirement of intravenous infusion of opioid analgesics for the last 8 hours; iii) the patient is able to walk or move without pain; iv) absence of spontaneous pain with a CPS (categorical pain score) of 1 or less
Measured: Day 5
Rate of secondary acute chest syndrome (ACS)(Efficacy Stage)
Defined as the proportion of patients with secondary ACS during the 14 days following randomization. Secondary ACS is defined as the combination after randomization of a clinical sign [chest pain or auscultatory abnormality (crepitants and/or bronchial breathing)] with a new pulmonary infiltrate (on chest film, thoracic scan, or lung ultrasound).
Measured: Day 14
Secondary outcomes (12)
Volume of transfused red blood cells and volume of exsanguinated blood
Measured: Between day-1 (randomization) and day-14
Pain intensity evaluated by categorical pain score
Pain intensity evaluated with categorical pain score (CPS). Patients will grade their pain (range 0-3 points, with 0, no pain; 1, mild pain, unaffected by mobilization; 2, moderate pain, increased by mobilization; 3, severe pain with disability) in seven body sites (all four limbs, ribs and sternum, head, and spine and pelvis)
Measured: Between day-1 (randomization) and day-14
Pain intensity evaluated by visual analogue scale
Pain intensity evaluated with the visual analogue pain scale (VAS) .It is presented as a 10 cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Measured: Between day-1 (randomization) and day-14
VOC duration
Measured: Day-14
VOC-free days
Measured: Day-14
Reticulocyte count
Measured: Day-2 and Day-5
Arterial blood gas
Arterial blood gas assessed at least once during the first 24 hours of treatment (if available)
Measured: Up to 24 hours
Cumulative doses of intravenous and subcutaneous opioids
Measured: Between day-1 (randomization) and day-14
Number of complicated VOC
A complicated VOC is defined as the occurrence of at least one of the following events between randomization and day-14: transfusion, exchange transfusion, mechanical ventilation, shock (catecholamine infusion), intensive care admission or death.
Measured: Day-14
Duration of hospital stay
Defined as the time from randomization to hospital discharge; patients still hospitalized at day-28 will be attributed a hospital stay of 28 days)
Measured: Day-28
Number of re-hospitalizations or emergency department consultations for VOC or ACS
Measured: Up to 28 days
Number of death (Mortality)
Measured: Day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start27 Apr 2020
- Primary completion27 Nov 2025 (estimated)
- Study completion27 Nov 2025 (estimated)
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 Sickle Cell DiseaseStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a comparative randomized controlled superiority open-label multi-arm multi-stage (MAMS) trial. The study will use a multi-arm multi-stage (MAMS) trial design with three stages and four arms (one control arm and three intervention arms). * "Pilot" stage: a formal safety/feasibility testing. Research arms will only continue to recruitment in the next stage if they have been shown to be both safe and feasible, although patient data from all patients and all stages will be included in the final analyses. * "Activity" stage: an interim comparison of activity using the rate of VOC resolution without complication at day-5 as primary endpoint. At the end of this stage, an interim analysis will be used in order to select the most promising experimental treatment and compare it to control in the subsequent stage ("pick the winner" strategy). * "Efficacy" stage: final comparison with secondary ACS at day-14 as the primary endpoint.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Orkyn'
- Responsible party
- Sponsor
- Investigators
- Armand Mekontso, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976180
- Sponsor's protocol ID
- P180303J
- Acronym
- OSONE
- Status last verified
- Oct 2024
- First submitted
- 24 May 2019
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Mekontso Dessap A, Habibi A, Guillaud C, Kassasseya C, Larrat C, Agbakou M, Tchoubou T, Candille C, Carpentier B, Landais M, Arlet JB, Fartoukh M, Desclaux A, Masseau A, Oziel J, Bouharaoua S, Affo C, Viglino D, Boukari L, Martin LE, Ngo S, Anguel N, Chantalat C, Bourgarit-Durand A, Genty I, Makowski C, Guillet S, Melica G, Lionnet F, Le Jeune S, Joseph L, Lanternier F, Cougoul P, Bertchansky I, Boue Y, Bartolucci P, Gendreau S, Audureau E. High flow oxygen for vaso-occlusive crisis: a multicentre, prospective, randomised, multi-arm, multi-stage clinical trial (OSONE). BMJ Open. 2025 Sep 17;15(9):e104564. doi: 10.1136/bmjopen-2025-104564.
PubMed 40967654
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Randomized, Multi-arm, Multi-stage Clinical Trial of High-flow Oxygen for Vaso-occlusive Pain Crisis in Adult Patients With Sickle Cell Disease;
- ClinicalTrials.gov ID
- NCT03976180
- Acronym / sponsor ID
- OSONE / P180303J
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, vaso-occlusive pain crisis, HFNO, ACS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Orkyn'
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 27 Nov 2025 (estimated)
- Study completion
- 27 Nov 2025 (estimated)
- First posted
- 5 Jun 2019 (actual)
- 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.
Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive pain crisis (VOC), which may evolve to acute chest syndrome (ACS), the most common cause of death among adult patients with SCD. Currently, there is no safe and effective treatment to abort VOC or prevent secondary ACS. Management of VOC mostly involve a symptomatic approach including hydration, analgesics, transfusion, and incentive spirometry, which was investigated in a very limited number of patients (<30).
The polymerisation of HbS is one major feature in the pathogenesis of vaso-occlusion. Among factors determining the rate and extent of HbS polymer formation, the hypoxic stimulus is one of the most potent and readily alterable. Current guidelines recommend oxygen therapy in patients with VOC in order to maintain a target oxygen saturation of 95%. Low-flow nasal oxygen (LFNO) is routinely used to achieve this normoxia approach, particularly in patients at risk of secondary ACS because they may experience acute desaturation. In contrast, various case series suggest a potential beneficial role of intensified oxygen therapy targeting hyperoxia for the management of VOC, particularly with the use of hyperbaric oxygen, but the latter is difficult to implement in routine clinical practice.
A recent high-flow nasal oxygen (HFNO) technology allows the delivery of humidified gas at high fraction of inspired oxygen (FiO2) through nasal cannula. The FiO2 can be adjusted up to 100% (allowing hyperoxia that may reverse sickling) and the flow can be increased up to 60 L/min (which generates positive airway pressure and dead space flushing, that may prevent evolution of VOC towards ACS by alleviating atelectasis and opioid-induced hypercapnia). In patients with acute respiratory failure, HFNO has been shown to improve patient's comfort, oxygenation, and survival as compared to standard oxygen or non-invasive ventilation.
The aim of the present study is to test the efficacy and safety of HFNO for the management of VOC and prevention of secondary ACS. The investigators will use a multi-arm multi-stage (MAMS) design to achieve these goals. HFNO will be delivered through AIRVO 2 (Fisher and Paykel Healthcare, New Zealand), a device that incorporates a turbine allowing its use in hospital wards.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a comparative randomized controlled superiority open-label multi-arm multi-stage (MAMS) trial. The study will use a multi-arm multi-stage (MAMS) trial design with three stages and four arms (one control arm and three intervention arms). * "Pilot" stage: a formal safety/feasibility testing. Research arms will only continue to recruitment in the next stage if they have been shown to be both safe and feasible, although patient data from all patients and all stages will be included in the final analyses. * "Activity" stage: an interim comparison of activity using the rate of VOC resolution without complication at day-5 as primary endpoint. At the end of this stage, an interim analysis will be used in order to select the most promising experimental treatment and compare it to control in the subsequent stage ("pick the winner" strategy). * "Efficacy" stage: final comparison with secondary ACS at day-14 as the primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| standard low-flow oxygen | Active comparator | Device: Stadard low-flow oxygenIn the control group, standard low-flow oxygen will be delivered via nasal prongs (LFNO), up to hospital discharge or secondary ACS onset, in order to achieve normoxia (target pulse oxymetry saturation of 95%). This strategy is in accordance with current recommendations and usual care; |
| HFNO with low FiO2 (21%-30%) | Experimental | Device: HFNO with low FiO2 (21%-30%)HFNO with low FiO2 (21%-30%) targeting normoxia: to test the effect of improved pulmonary function; |
| HFNO with intermediate FiO2 (50%) | Experimental | Device: HFNO with intermediate FiO2 (50%)HFNO with intermediate FiO2 (50%): to test the combined effect of improved pulmonary function and moderate hyperoxia; in this group, FiO2 will be set at 50% during the first 24 hours of intervention to target moderate hyperoxia, then reduced to 21-30% during the following 48 hours to target normoxia |
| HFNO with high FiO2 (100%) | Experimental | Device: HFNO with high FiO2 (100%)HFNO with high FiO2 (100%): to test the combined effect of improved pulmonary function and intense hyperoxia; in this group, FiO2 will be set at 100% during the first 24 hours of intervention to target intense hyperoxia, then reduced to 21-30% during the following 48 hours to target normoxia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+);
- VOC as defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, that requires opioids and is not attributable to other causes;
- Intermediate-to-high risk for secondary ACS derived from the PRESEV score (Bartolucci et al, EBioMedicine 2016) as follows: a reticulocyte count >216 G/L OR at least two of the followings : i) spine and/or pelvis CPS >1; ii) leucocyte count >11G/L; iii) hemoglobin ≤ 9 g/dL; in case of long-term treatment by hydroxyurea, only one of the above mentioned criteria will be needed, given its effects on hemoglobin, leucocyte and reticulocytes counts;
- Informed consent;
Key exclusion criteria (9 listed)
- The presence at inclusion of a primary ACS. Primary ACS is defined by the combination at time of randomization of a clinical sign [chest pain or auscultatory abnormality (crepitants and/or bronchial breathing)] with a new pulmonary infiltrate (on chest film, thoracic scan, or lung ultrasound);
- VOC with need of parenteral opioids lasting longer than 72 hours at time of inclusion;
- Known pregnancy or current lactation; Women of child bearing potential will be tested for pregnancy before inclusion;
- Known cerebral vasculopathy or past medical history of stroke, due to Moya Moya or persisting visible macrovessel stenosis/occlusion;
- Known ischemic heart disease or typical chest angina;
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 |
|---|---|---|
| Stadard low-flow oxygenAlso: Control groupIn the control group, standard low-flow oxygen will be delivered via nasal prongs (LFNO), up to hospital discharge or secondary ACS onset, in order to achieve normoxia (target pulse oxymetry saturation of 95%). This strategy is in accordance with current recommendations and usual care | Device | standard low-flow oxygen |
| HFNO with low FiO2 (21%-30%)Also: Intervention groupHFNO with low FiO2 (21%-30%) targeting normoxia: to test the effect of improved pulmonary function | Device | HFNO with low FiO2 (21%-30%) |
| HFNO with intermediate FiO2 (50%)Also: Intervention groupIn this group, FiO2 will be set at 50% during the first 24 hours of intervention to target moderate hyperoxia, then reduced to 21-3025% during the following 48 hours to target normoxia | Device | HFNO with intermediate FiO2 (50%) |
| HFNO with high FiO2 (100%)Also: Intervention groupIn this group, FiO2 will be set at 100% during the first 24 hours of intervention to target intense hyperoxia, then reduced to 21-3025% during the following 48 hours to target normoxia | Device | HFNO with high FiO2 (100%) |
Primary outcome
Rate of cardiac and neurologic related events (Pilot Stage)
Time frame: At the end end of the "pilot stage" and up to 28 days
This endpoint will be assessed at the end of the "pilot stage" and throughout the entire study for cumulative safety information. Research arms will only continue to recruitment in the next stage if they have been shown to be both safe (<5 cardiac or neurologic related events, in the arm during the pilot phase as defined by one of the following: acute coronary syndrome, acute ischemic stroke, or seizure) and feasible (<8 definitive discontinuations before day-2 due to patient's intolerance), although patient data from all patients and all stages will be included in the final analyses.
Rate of vaso-occlusive pain crisis (VOC) resolution without complication (Activity stage)
Time frame: Day 5
VOC will be considered terminated when at least 3 of the following 4 criteria are met at two consecutive assessments: i) absence of fever for 8 hours; ii) absence of pain progression and no requirement of intravenous infusion of opioid analgesics for the last 8 hours; iii) the patient is able to walk or move without pain; iv) absence of spontaneous pain with a CPS (categorical pain score) of 1 or less
Rate of secondary acute chest syndrome (ACS)(Efficacy Stage)
Time frame: Day 14
Defined as the proportion of patients with secondary ACS during the 14 days following randomization. Secondary ACS is defined as the combination after randomization of a clinical sign [chest pain or auscultatory abnormality (crepitants and/or bronchial breathing)] with a new pulmonary infiltrate (on chest film, thoracic scan, or lung ultrasound).
12 secondary outcomes
Volume of transfused red blood cells and volume of exsanguinated blood
Time frame: Between day-1 (randomization) and day-14
Pain intensity evaluated by categorical pain score
Time frame: Between day-1 (randomization) and day-14
Pain intensity evaluated by visual analogue scale
Time frame: Between day-1 (randomization) and day-14
VOC duration
Time frame: Day-14
VOC-free days
Time frame: Day-14
Reticulocyte count
Time frame: Day-2 and Day-5
Arterial blood gas
Time frame: Up to 24 hours
Cumulative doses of intravenous and subcutaneous opioids
Time frame: Between day-1 (randomization) and day-14
Number of complicated VOC
Time frame: Day-14
Duration of hospital stay
Time frame: Day-28
Number of re-hospitalizations or emergency department consultations for VOC or ACS
Time frame: Up to 28 days
Number of death (Mortality)
Time frame: Day-28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Derived from this study: PubMed 40967654Mekontso Dessap A, Habibi A, Guillaud C, Kassasseya C, Larrat C, Agbakou M, Tchoubou T, Candille C, Carpentier B, Landais M, Arlet JB, Fartoukh M, Desclaux A, Masseau A, Oziel J, Bouharaoua S, Affo C, Viglino D, Boukari L, Martin LE, Ngo S, Anguel N, Chantalat C, Bourgarit-Durand A, Genty I, Makowski C, Guillet S, Melica G, Lionnet F, Le Jeune S, Joseph L, Lanternier F, Cougoul P, Bertchansky I, Boue Y, Bartolucci P, Gendreau S, Audureau E. High flow oxygen for vaso-occlusive crisis: a multicentre, prospective, randomised, multi-arm, multi-stage clinical trial (OSONE). BMJ Open. 2025 Sep 17;15(9):e104564. doi: 10.1136/bmjopen-2025-104564.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Armand Mekontso study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stadard low-flow oxygen, HFNO with low FiO2 (21%-30%) and HFNO with intermediate FiO2 (50%) in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Jul 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armand Mekontso, MD, PhD (+33 (1) 49 81 23 94, armand.dessap@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cardiac and neurologic related events (Pilot Stage) (time frame: At the end end of the "pilot stage" and up to 28 days). The study lists 3 primary outcomes in all. 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 NCT03976180, 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 28 Jul 2025.