Anaesthesiology and Critical Care Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
Medical Intensive Care Unit, Hospital Dax Côte d'Argent, Dax, France.
BMJ Open. 2020 Feb 18;10(2):e034701. doi: 10.1136/bmjopen-2019-034701.
Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room. Standard oxygen therapy (SOT) is used to prevent hypoxaemia. Data suggest that risk factors for hypoxaemia under deep sedation during GIE are obstructive sleep apnoea syndrome, a body mass index above 30 kg/m², high blood pressure, diabetes, heart disease, age over 60 years old, high American Society of Anesthesiologists physical status class and the association of upper and lower GIE. High-flow nasal oxygenation (HFNO) may potentially improve oxygenation during GIE under deep sedation. We hypothesised that HFNO could decrease the incidence of hypoxaemia in comparison with SOT.
The ODEPHI (High-flow nasal xygenation versus standar oxygenation for gastrointestinal ndoscoy wit sedation. The prospectve multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room. Three hundred and eighty patients will be randomised with a 1:1 ratio in two parallel groups.The primary outcome is the occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO) below or equal to 92% during the GIE procedure. Secondary outcomes include prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events.
This study has been approved by the ethics committee (CPP Sud Est Paris V, France), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals. As provided for by French law, patients participating in the study are informed that they have the possibility to ask the investigators, once the study is completed, to be informed of the overall results of the study. Thus, a summary of the results will be sent by post to the participants on request.
ClinicalTrials.gov Registry (NCT03829293).
在胃肠内镜（GI）检查过程中，当在检查室内进行深度镇静时，低氧血症是一种主要并发症（上/下）。标准氧疗（SOT）用于预防低氧血症。数据表明，在 GI 深度镇静下发生低氧血症的危险因素包括阻塞性睡眠呼吸暂停综合征、体重指数超过 30kg/m²、高血压、糖尿病、心脏病、年龄超过 60 岁、美国麻醉医师协会身体状况分级高以及上、下 GI 的联合。高流量鼻氧可能潜在改善深度镇静下 GI 检查时的氧合作用。我们假设 HFNO 与 SOT 相比可降低低氧血症的发生率。
ODEPHI（高流量鼻氧与镇静下胃肠内镜的标准氧疗）研究是一项多中心随机对照试验，比较了在检查室内由麻醉师给予深度镇静时，HFNO 与 SOT 在 GI（上/下）检查中的应用。将 380 例患者随机分为 1:1 两组，平行比较。主要结局为检查过程中发生低氧血症，定义为外周毛细血管血氧饱和度（SpO₂）脉搏血氧仪测量值低于或等于 92%。次要结局包括低氧血症持续时间延长、严重低氧血症、需要维持上呼吸道通畅的操作以及其他不良事件。
该研究已获得伦理委员会（法国 Sud Est Paris V 地区伦理委员会）批准，患者在知情同意后纳入研究。研究结果将提交给同行评审期刊发表。根据法国法律规定，参与研究的患者有权在研究完成后要求研究人员告知他们有关研究总体结果的信息。因此，将根据要求通过邮寄向参与者发送结果摘要。
ClinicalTrials.gov 注册号（NCT03829293）。
