Sickle Cell Disease (SCD)SIPAPNCT07703566
CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease
A study testing O2+CPAP group in people with Sickle Cell Disease (SCD) and Acute Chest Syndrome (ACS), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Sickle cell disease (SCD) is a severe hemoglobinopathy, considered the first monogenic disease in the world. Acute chest syndrome (ACS), one of the most frequent and serious complications of SCD, is defined by the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease (SCD), Acute Chest Syndrome (ACS)
- What is being tested?
- O2+CPAP group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- SCD patient of all genotypes (SS, SC, S/β0 and S/β+)
- Age ≥ 18 years old
- Hospitalised for ACS (defined as the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging)
- Requiring supplemental O2 ≥ 2 L/min for SpO2 ≥ 95%
- Informed consent from the patient
- Affiliated to a social security regime
Who cannot join
- Patient having both ACS criteria and need for supplemental O2 ≥ 2 L/min for SpO2 ≥ 95% since more than 48 hours
- Requirement for home supplemental O2 or home CPAP / NIV.
- Signs of worsening respiratory failure mandating intubation (as defined in (Helms et al., 2024))
- Current enrolment in another interventional research concerning a respiratory support during ACS
- Known legal incapacity (patients under guardianship or curatorship)
- Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease
- Absolute contraindications to CPAP, including any of the following: patient not cooperating or opposing the technique, pneumothorax not drained, chest wound blowing, uncontrollable vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, traumatic tetraplegia at the initial phase, cardiac arrest, shock (need for vasopressor), or Coma Glasgow scale <12.
- Known pregnancy, breast feeding, women with childbearing potential will be tested for pregnancy and excluded if pregnant,
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Armand MEKONTSO-DESSAP contact
About this study
Official title: Continuous Positive Airway Pressure for Hypoxemic Acute Chest Syndrome in Patients With Sickle Cell Disease
Sickle cell disease (SCD) is a severe hemoglobinopathy, considered the first monogenic disease in the world. Acute chest syndrome (ACS), one of the most frequent and serious complications of SCD, is defined by the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging. ACS is characterized by lung consolidation, severe pulmonary vascular dysfunction, with potential role for regional alveolar hypoxia. Therefore, improving alveolar oxygenation and limiting lung consolidation are key objectives of the treatment of ACS, in addition to ensuring pain relief and giving blood transfusions and antibiotics. Bilevel non-invasive ventilation failed in improving outcomes during ACS (Fartoukh 2010). These results are in accordance with those reported in other forms of acute lung injury (Frat 2015), with conflicting results. Among other explanations, NIV may favour high tidal volume ventilation leading to patient self-inflicted lung injury (P-SILI) (Carteaux 2016). Continuous positive airway pressure (CPAP) is a simple to use and affordable technique for non-invasive ventilatory support, that theoretically exposes to a lower risk of P-SILI (Carteaux 2021). In patients with acute hypoxemic respiratory failure (AHRF), applying a positive pressure to the airway opening has been shown to mitigate the reduction in functional residual capacity and to improve respiratory mechanics and gas exchange. In a randomized controlled trial (RCT) conducted in patients with AHRF, CPAP achieved early physiologic improvement (Delclaux 2000). Recent results also suggest that CPAP reduces the composite outcome of intubation or death in adults with AHRF due to COVID-19 in a large multicentre study (RECOVERY-R) (Perkins 2022). In addition, CPAP can be safely used at early stages in the wards, with a frugal approach, using virtual valves (Carteaux 2021). In patients with SCD, CPAP has shown benefits when used at night in children with sleep apnea (Marshall 2009), or for the peri-operative management (Leff 2007). CPAP is also used in clinical practice for hypoxemic ACS (Heilbronner 2021), but it has not been formally assessed in this setting.
- Being tested
- O2+CPAP group
- Keywords
- CPAP, Acute chest syndrome (ACS), Sickle cell disease (SCD), supplemental oxygen
- Medical subject headings
- Anemia, Sickle Cell, Acute Chest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2+CPAP groupOther
ACS episodes assigned to this group will receive supplemental O2 in addition to periods of CPAP. CPAP will target a positive pressure between 5 and 10 cmH2O. CPAP will be given discontinuously (≥6 hours/day) based on patient tolerance . CPAP sessions will be stopped when the patient achieves the criteria for cessation of supplemental O2. These criteria will be the same as in the O2 group. No sedation will be used for CPAP tolerance.
| Study group | Role | What they receive |
|---|---|---|
| O2+CPAP group | Experimental | ACS episodes assigned to this group will receive supplemental O2 in addition to periods of CPAP. Receives: Other: O2+CPAP group |
| O2 group | No intervention | ACS episodes assigned to the O2 group will receive supplemental O2 delivered through nasal cannula or high flow nasal cannula (for needs ≤6, and >6L/min, respectively) until endotracheal intubation, death, or fulfilment of O2 delivery cessation criteria (SpO2 ≥95% without supplemental O2). SpO2 will be measured on room air, at least every 12 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to résolution of acute chest syndrome (ACS)
time to resolution of ACS, defined as the time from randomization to the joint resolution of fever (body temperature < 38°C), chest pain (visual analog scale, VAS ≤ 3 cm, morphine ≤ 40mg/24h), dyspnea (VAS ≤ 3 cm, respiratory rate < 25/min, no ventilatory support), and hypoxemia (SpO2 > 92% on room air) (Mekontso Dessap, Habibi, et al., 2025).
If a VAS is unavailable, a verbal rating scale will be used. Resolution of ACS will be assessed every 8 to 12 hours and will be considered achieved if sustained across 2 to 3 consecutive evaluations (i.e., over a 24-hour period).
Measured: Up to randomization
Secondary outcomes (13)
Mortality
All-cause mortality
Measured: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Length of hospital stay
Measured: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Length of ICU stay
Measured: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Need for catecholamine infusion
dobutamine, dopamine, adrenaline or noradrenaline
Measured: From randomisation to discharge or Day-28
Number of red blood cell units transfused
Measured: From randomisation to discharge or Day-28
Volume of blood exsanguination
Measured: From randomisation to discharge or Day-28
Need for invasive ventilation
Measured: From randomisation to discharge or Day-28
Number of days free from any respiratory support
Measured: From randomisation to discharge or Day-28
Need for antibiotics therapy
Measured: From randomisation to discharge or Day-28
Change in arterial blood gases (PaO2/FiO2 ratio), routine laboratory markers (lacticodeshydrogenase), and chest imaging (X-ray or lung ultrasound score)
Measured: within 3 days post-randomisation
Readmissions for VOC
Measured: up to 3 months
Readmissions for ACS
Measured: up to 3 months
Quality of life questionary
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) Index score. The index score ranges from less than 0 (health states considered worse than death; country-specific minimum) to 1.0 (full health). Higher scores indicate better health-related quality of life.tatus and monitor changes over time.
Measured: At inclusion, Day-28, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease (SCD)Studies 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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armand MEKONTSO-DESSAP, MD, PhD, Study chair, Assistance public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703566
- Sponsor's protocol ID
- APHP251577
- Other IDs
- 2026-A00423-48
- Acronym
- SIPAP
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure for Hypoxemic Acute Chest Syndrome in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07703566
- Acronym / sponsor ID
- SIPAP / APHP251577
- Keywords
- CPAP, Acute chest syndrome (ACS), Sickle cell disease (SCD), supplemental oxygen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Jul 2026 (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 a severe hemoglobinopathy, considered the first monogenic disease in the world. Acute chest syndrome (ACS), one of the most frequent and serious complications of SCD, is defined by the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging. ACS is characterized by lung consolidation, severe pulmonary vascular dysfunction, with potential role for regional alveolar hypoxia. Therefore, improving alveolar oxygenation and limiting lung consolidation are key objectives of the treatment of ACS, in addition to ensuring pain relief and giving blood transfusions and antibiotics. Bilevel non-invasive ventilation failed in improving outcomes during ACS (Fartoukh 2010). These results are in accordance with those reported in other forms of acute lung injury (Frat 2015), with conflicting results. Among other explanations, NIV may favour high tidal volume ventilation leading to patient self-inflicted lung injury (P-SILI) (Carteaux 2016). Continuous positive airway pressure (CPAP) is a simple to use and affordable technique for non-invasive ventilatory support, that theoretically exposes to a lower risk of P-SILI (Carteaux 2021). In patients with acute hypoxemic respiratory failure (AHRF), applying a positive pressure to the airway opening has been shown to mitigate the reduction in functional residual capacity and to improve respiratory mechanics and gas exchange. In a randomized controlled trial (RCT) conducted in patients with AHRF, CPAP achieved early physiologic improvement (Delclaux 2000). Recent results also suggest that CPAP reduces the composite outcome of intubation or death in adults with AHRF due to COVID-19 in a large multicentre study (RECOVERY-R) (Perkins 2022). In addition, CPAP can be safely used at early stages in the wards, with a frugal approach, using virtual valves (Carteaux 2021). In patients with SCD, CPAP has shown benefits when used at night in children with sleep apnea (Marshall 2009), or for the peri-operative management (Leff 2007). CPAP is also used in clinical practice for hypoxemic ACS (Heilbronner 2021), but it has not been formally assessed in this setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O2+CPAP group | Experimental | Other: O2+CPAP groupACS episodes assigned to this group will receive supplemental O2 in addition to periods of CPAP. |
| O2 group | No intervention | –ACS episodes assigned to the O2 group will receive supplemental O2 delivered through nasal cannula or high flow nasal cannula (for needs ≤6, and >6L/min, respectively) until endotracheal intubation, death, or fulfilment of O2 delivery cessation criteria (SpO2 ≥95% without supplemental O2). SpO2 will be measured on room air, at least every 12 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- SCD patient of all genotypes (SS, SC, S/β0 and S/β+)
- Age ≥ 18 years old
- Hospitalised for ACS (defined as the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging)
- Requiring supplemental O2 ≥ 2 L/min for SpO2 ≥ 95%
- Informed consent from the patient
Key exclusion criteria (8 listed)
- Patient having both ACS criteria and need for supplemental O2 ≥ 2 L/min for SpO2 ≥ 95% since more than 48 hours
- Requirement for home supplemental O2 or home CPAP / NIV.
- Signs of worsening respiratory failure mandating intubation (as defined in (Helms et al., 2024))
- Current enrolment in another interventional research concerning a respiratory support during ACS
- Known legal incapacity (patients under guardianship or curatorship)
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 |
|---|---|---|
| O2+CPAP groupACS episodes assigned to this group will receive supplemental O2 in addition to periods of CPAP. CPAP will target a positive pressure between 5 and 10 cmH2O. CPAP will be given discontinuously (≥6 hours/day) based on patient tolerance . CPAP sessions will be stopped when the patient achieves the criteria for cessation of supplemental O2. These criteria will be the same as in the O2 group. No sedation will be used for CPAP tolerance. | Other | O2+CPAP group |
Primary outcome
Time to résolution of acute chest syndrome (ACS)
Time frame: Up to randomization
time to resolution of ACS, defined as the time from randomization to the joint resolution of fever (body temperature < 38°C), chest pain (visual analog scale, VAS ≤ 3 cm, morphine ≤ 40mg/24h), dyspnea (VAS ≤ 3 cm, respiratory rate < 25/min, no ventilatory support), and hypoxemia (SpO2 > 92% on room air) (Mekontso Dessap, Habibi, et al., 2025). If a VAS is unavailable, a verbal rating scale will be used. Resolution of ACS will be assessed every 8 to 12 hours and will be considered achieved if sustained across 2 to 3 consecutive evaluations (i.e., over a 24-hour period).
13 secondary outcomes
Mortality
Time frame: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Length of hospital stay
Time frame: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Length of ICU stay
Time frame: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Need for catecholamine infusion
Time frame: From randomisation to discharge or Day-28
Number of red blood cell units transfused
Time frame: From randomisation to discharge or Day-28
Volume of blood exsanguination
Time frame: From randomisation to discharge or Day-28
Need for invasive ventilation
Time frame: From randomisation to discharge or Day-28
Number of days free from any respiratory support
Time frame: From randomisation to discharge or Day-28
Need for antibiotics therapy
Time frame: From randomisation to discharge or Day-28
Change in arterial blood gases (PaO2/FiO2 ratio), routine laboratory markers (lacticodeshydrogenase), and chest imaging (X-ray or lung ultrasound score)
Time frame: within 3 days post-randomisation
Readmissions for VOC
Time frame: up to 3 months
Readmissions for ACS
Time frame: up to 3 months
Quality of life questionary
Time frame: At inclusion, Day-28, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- 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.
Armand MEKONTSO-DESSAP contact
Armand MEKONTSO-DESSAP, MD, PhD study chair
Assistance public Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing O2+CPAP group in people with Sickle Cell Disease (SCD) and Acute Chest Syndrome (ACS), 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samia BALOUL (01 49 81 33 85, samia.baloul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to résolution of acute chest syndrome (ACS) (time frame: Up to randomization). 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 23 Jul 2026.