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CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease (SIPAP)

21 juli 2026 uppdaterad av: Assistance Publique - Hôpitaux de Paris

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

140

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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,

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: O2+CPAP group
ACS episodes assigned to this group will receive supplemental O2 in addition to periods of CPAP.
Övrig: O2+CPAP group
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.
Inget ingripande: O2 group
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to résolution of acute chest syndrome (ACS)
Tidsram: 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).
Up to randomization

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mortality
Tidsram: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
All-cause mortality
up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Length of hospital stay
Tidsram: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Length of ICU stay
Tidsram: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
Need for catecholamine infusion
Tidsram: From randomisation to discharge or Day-28
dobutamine, dopamine, adrenaline or noradrenaline
From randomisation to discharge or Day-28
Number of red blood cell units transfused
Tidsram: From randomisation to discharge or Day-28
From randomisation to discharge or Day-28
Volume of blood exsanguination
Tidsram: From randomisation to discharge or Day-28
From randomisation to discharge or Day-28
Need for invasive ventilation
Tidsram: From randomisation to discharge or Day-28
From randomisation to discharge or Day-28
Number of days free from any respiratory support
Tidsram: From randomisation to discharge or Day-28
From randomisation to discharge or Day-28
Need for antibiotics therapy
Tidsram: From randomisation to discharge or Day-28
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)
Tidsram: within 3 days post-randomisation
within 3 days post-randomisation
Readmissions for VOC
Tidsram: up to 3 months
up to 3 months
Readmissions for ACS
Tidsram: up to 3 months
up to 3 months
Quality of life questionary
Tidsram: At inclusion, Day-28, and 3 months
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.
At inclusion, Day-28, and 3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Utredare

  • Studiestol: Armand MEKONTSO-DESSAP, MD, PhD, Assistance public Hôpitaux de Paris

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 oktober 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

8 juli 2026

Först inskickad som uppfyllde QC-kriterierna

8 juli 2026

Första postat (Faktisk)

14 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • APHP251577
  • 2026-A00423-48 (Annan identifierare: Ministère chargé de la Santé, France)

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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