Declercq Pierre-Louis, Fournel Isabelle, Demeyere Matthieu, Ksiazek Eléa, Meunier-Beillard Nicolas, Rivière Antoine, Clarot Caroline, Maizel Julien, Schnell David, Plantefeve Gaetan, Ampere Alexandre, Daubin Cédric, Sauneuf Bertrand, Kalfon Pierre, Federici Laura, Redureau Élise, Bousta Mehdi, Lagache Laurie, Vanderlinden Thierry, Nseir Saad, La Combe Béatrice, Bourdin Gaël, Monchi Mehran, Nyunga Martine, Ramakers Michel, Oulehri Walid, Georges Hugues, Salmon Gandonniere Charlotte, Badie Julio, Delbove Agathe, Monnet Xavier, Beduneau Gaetan, Artaud-Macari Élise, Abraham Paul, Delberghe Nicolas, Le Bouar Gurvan, Miailhe Arnaud-Felix, Hraiech Sami, Bironneau Vanessa, Sedillot Nicholas, Hoppe Marie-Anne, Barbar Saber Davide, Calcaianu George-Daniel, Dellamonica Jean, Terzi Nicolas, Delpierre Cyrille, Gélinotte Stéphanie, Rigaud Jean-Philippe, Labruyère Marie, Georges Marjolaine, Binquet Christine, Quenot Jean-Pierre
Service de Médecine Intensive-Réanimation, Hospital Centre Dieppe, Dieppe, France.
Centre d'Investigation Clinique INSERM 1432, Centre Hospitalier Universitaire de Dijon, Dijon, France.
BMJ Open. 2022 Apr 22;12(4):e057368. doi: 10.1136/bmjopen-2021-057368.
Prognosis of patients with COVID-19 depends on the severity of the pulmonary affection. The most severe cases may progress to acute respiratory distress syndrome (ARDS), which is associated with a risk of long-term repercussions on respiratory function and neuromuscular outcomes. The functional repercussions of severe forms of COVID-19 may have a major impact on quality of life, and impair the ability to return to work or exercise. Social inequalities in healthcare may influence prognosis, with socially vulnerable individuals more likely to develop severe forms of disease. We describe here the protocol for a prospective, multicentre study that aims to investigate the influence of social vulnerability on functional recovery in patients who were hospitalised in intensive care for ARDS caused by COVID-19. This study will also include an embedded qualitative study that aims to describe facilitators and barriers to compliance with rehabilitation, describe patients' health practices and identify social representations of health, disease and care.
The "Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status" (RECOVIDS) study is a mixed-methods, observational, multicentre cohort study performed during the routine follow-up of post-intensive care unit (ICU) functional recovery after ARDS. All patients admitted to a participating ICU for PCR-proven SARS-CoV-2 infection and who underwent chest CT scan at the initial phase AND who received respiratory support (mechanical or not) or high-flow nasal oxygen, AND had ARDS diagnosed by the Berlin criteria will be eligible. The primary outcome is the presence of lung sequelae at 6 months after ICU discharge, defined either by alterations on pulmonary function tests, oxygen desaturation during a standardised 6 min walk test or fibrosis-like pulmonary findings on chest CT. Patients will be considered to be socially disadvantaged if they have an "Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examen de Santé" (EPICES) score ≥30.17 at inclusion.
The study protocol and the informed consent form were approved by an independent ethics committee (Comité de Protection des Personnes Sud Méditerranée II) on 10 July 2020 (2020-A02014-35). All patients will provide informed consent before participation. Findings will be published in peer-reviewed journals and presented at national and international congresses.
NCT04556513.
新型冠状病毒肺炎（COVID-19）患者的预后取决于肺部病变的严重程度。最严重的病例可能进展为急性呼吸窘迫综合征（ARDS），这与呼吸功能和神经肌肉预后的长期影响风险相关。COVID-19严重形式的功能影响可能对生活质量产生重大影响，并损害重返工作或锻炼的能力。医疗保健方面的社会不平等可能影响预后，社会弱势群体更有可能患上严重形式的疾病。我们在此描述一项前瞻性、多中心研究的方案，该研究旨在调查社会脆弱性对因COVID-19导致ARDS而入住重症监护病房的患者功能恢复的影响。这项研究还将包括一项嵌入式定性研究，旨在描述康复依从性的促进因素和障碍，描述患者的健康行为，并确定健康、疾病和护理的社会认知。
“COVID-19所致急性呼吸窘迫综合征（ARDS）的功能恢复：社会经济地位的影响”（RECOVIDS）研究是一项混合方法、观察性、多中心队列研究，在ARDS后重症监护病房（ICU）功能恢复的常规随访期间进行。所有因经PCR证实的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染而入住参与研究的ICU，且在初始阶段接受胸部CT扫描、接受呼吸支持（机械通气或非机械通气）或高流量鼻导管吸氧，并且根据柏林标准诊断为ARDS的患者均符合条件。主要结局是ICU出院后6个月时肺部后遗症的存在情况，定义为肺功能测试异常、标准化6分钟步行试验期间的氧饱和度下降或胸部CT上类似纤维化的肺部表现。如果患者在纳入时的“健康检查中心的脆弱性和健康不平等评估”（EPICES）评分≥30.17，则将被视为社会弱势群体。
研究方案和知情同意书于2020年7月10日获得独立伦理委员会（南地中海第二地区保护人类委员会）批准（2020-A02014-35）。所有患者在参与前将提供知情同意。研究结果将发表在同行评审期刊上，并在国内和国际大会上展示。
NCT04556513。
