CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease (SIPAP)
2026年7月21日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
140
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Samia BALOUL
- 電話番号：01 49 81 33 85
- メール：samia.baloul@aphp.fr
研究連絡先のバックアップ
- 名前：Armand MEKONTSO-DESSAP
- メール：armand.dessap@aphp.fr
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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,
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to résolution of acute chest syndrome (ACS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mortality
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：within 3 days post-randomisation
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within 3 days post-randomisation
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Readmissions for VOC
時間枠：up to 3 months
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up to 3 months
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Readmissions for ACS
時間枠：up to 3 months
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up to 3 months
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Quality of life questionary
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Armand MEKONTSO-DESSAP, MD, PhD、Assistance public Hôpitaux de Paris
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年10月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月23日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- APHP251577
- 2026-A00423-48 (その他の識別子：Ministère chargé de la Santé, France)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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