CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease (SIPAP)
2026년 7월 21일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
140
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Samia BALOUL
- 전화번호: 01 49 81 33 85
- 이메일: samia.baloul@aphp.fr
연구 연락처 백업
- 이름: Armand MEKONTSO-DESSAP
- 이메일: armand.dessap@aphp.fr
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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,
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: O2+CPAP group
ACS episodes assigned to this group will receive supplemental O2 in addition to periods of CPAP.
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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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to résolution of acute chest syndrome (ACS)
기간: Up to randomization
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mortality
기간: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
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All-cause mortality
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up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
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Length of hospital stay
기간: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
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up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
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Length of ICU stay
기간: up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
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up to hospital discharge or day-28 after randomisation (whichever occurs first), and at 3 months after randomisation.
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Need for catecholamine infusion
기간: From randomisation to discharge or Day-28
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dobutamine, dopamine, adrenaline or noradrenaline
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From randomisation to discharge or Day-28
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Number of red blood cell units transfused
기간: From randomisation to discharge or Day-28
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From randomisation to discharge or Day-28
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Volume of blood exsanguination
기간: From randomisation to discharge or Day-28
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From randomisation to discharge or Day-28
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Need for invasive ventilation
기간: From randomisation to discharge or Day-28
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From randomisation to discharge or Day-28
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Number of days free from any respiratory support
기간: From randomisation to discharge or Day-28
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From randomisation to discharge or Day-28
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Need for antibiotics therapy
기간: From randomisation to discharge or Day-28
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From randomisation to discharge or Day-28
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Change in arterial blood gases (PaO2/FiO2 ratio), routine laboratory markers (lacticodeshydrogenase), and chest imaging (X-ray or lung ultrasound score)
기간: within 3 days post-randomisation
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within 3 days post-randomisation
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Readmissions for VOC
기간: up to 3 months
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up to 3 months
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Readmissions for ACS
기간: up to 3 months
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up to 3 months
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Quality of life questionary
기간: At inclusion, Day-28, and 3 months
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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.
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At inclusion, Day-28, and 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Armand MEKONTSO-DESSAP, MD, PhD, Assistance public Hôpitaux de Paris
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2028년 10월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 7월 8일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- APHP251577
- 2026-A00423-48 (기타 식별자: Ministère chargé de la Santé, France)
개별 참가자 데이터(IPD) 계획
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아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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