CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease (NCT07703566) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease
140 participantsStarted 2026-09-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing CPAP — the same kind of breathing machine used for sleep apnea — as a treatment during an acute chest syndrome episode; is that something my care team would even consider for me given how my ACS episodes have gone in the past?
2The trial isn't recruiting yet, so if I have an acute chest syndrome crisis soon, would there be any way to participate, or should we focus entirely on the standard treatments available right now?
3Since this is listed as 'Phase NA,' which often means it's a device or procedure study rather than a drug trial, what does my doctor think is actually known — or still unknown — about the safety of using CPAP during an acute chest syndrome episode in sickle cell patients?
4The trial is measuring how quickly ACS resolves with CPAP — but how does that compare to how my ACS has typically been managed, and would adding CPAP change anything about my current treatment plan?
5If this trial does open and I might be eligible, what would participation actually look like during a hospitalization — would I be connected to the CPAP machine the whole time, and how might that affect my comfort or other care I'd be receiving?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.