Uzun Davut Deniz, Zimmermann Benjamin P, Knoeller Sebastian, Kirchner Marietta, Mohr Stefan, Weigand Markus A, Zivkovic Aleksandar R, Schmitt Felix C F
Department of Anesthesiology, Heidelberg University Medical Faculty, Heidelberg, Germany
Department of Anesthesiology, Heidelberg University Medical Faculty, Heidelberg, Germany.
BMJ Open. 2025 May 2;15(5):e096842. doi: 10.1136/bmjopen-2024-096842.
Adverse events during paediatric anaesthesia are common, with hypoxaemia during the induction period being a leading cause, as infants and children are particularly vulnerable to hypoxaemia during periods of apnoea. The administration of supplementary oxygen, referred to as apnoeic oxygenation, has been shown to prolong safe apnoea times and increase first-pass intubation success rates. Despite these benefits, apnoeic oxygenation is not routinely used in paediatric anaesthesia. Low-flow apnoeic oxygenation, delivered via a standard nasal cannula, is a simple approach to provide supplementary oxygen during paediatric airway management without requiring additional equipment. However, its efficacy in airway management during elective surgeries has not been adequately studied.
The ApOx-Pedi-Trial is a single-centre, cluster randomised, controlled clinical trial comparing the use of low-flow apnoeic oxygenation during the induction of general anaesthesia in infants and children up to 6 years of age undergoing elective surgery at the Department of Pediatric Surgery at Heidelberg University Hospital to standard of care (no apnoeic oxygenation). Randomisation is conducted using a weekly cluster randomisation method, where all patients presenting for surgery in a given week either receive apnoeic oxygenation or standard of care during the induction of general anaesthesia, based on the week's group allocation.The study population will consist of two independent, age-stratified cohorts (<24 months and >24 months to 6 years), each including 100 patients. Statistical analysis of study endpoints will be conducted separately for each cohort to allow for age-specific assessment of outcomes.The primary objective of this trial is to evaluate whether apnoeic oxygenation can prevent a decrease in transcutaneous haemoglobin saturation (SpO₂) during the induction of general anaesthesia in infants and children. The primary outcome measure will be the lowest recorded SpO₂ value throughout the apnoeic period.
The ApOx-Pedi-Trial received permission from the local ethics committee (Ethics Committee of the medical faculty at Heidelberg University, Heidelberg, Germany) under the registration number S-074-2024. The study is following institutional Guidelines and the Declaration of Helsinki of 1975 in its most recent version. Trial results will be submitted to peer-reviewed journals and presented at national and international conferences.
The trial is prospectively registered on ClinicalTrials.gov with the number NCT06576596.
小儿麻醉期间的不良事件很常见，诱导期低氧血症是主要原因之一，因为婴儿和儿童在呼吸暂停期间特别容易发生低氧血症。补充氧气（即呼吸暂停氧合）已被证明可延长安全呼吸暂停时间并提高首次插管成功率。尽管有这些益处，但呼吸暂停氧合在小儿麻醉中并未常规使用。通过标准鼻导管进行的低流量呼吸暂停氧合是在小儿气道管理期间提供补充氧气的一种简单方法，无需额外设备。然而，其在择期手术气道管理中的疗效尚未得到充分研究。
ApOx-Pedi试验是一项单中心、整群随机对照临床试验，比较海德堡大学医院小儿外科对6岁及以下接受择期手术的婴幼儿在全身麻醉诱导期间使用低流量呼吸暂停氧合与标准治疗（无呼吸暂停氧合）的效果。采用每周整群随机方法进行随机分组，在给定的一周内，所有前来手术的患者根据当周的分组情况，在全身麻醉诱导期间接受呼吸暂停氧合或标准治疗。研究人群将由两个独立的、按年龄分层的队列组成（<24个月和>24个月至6岁），每个队列包括100名患者。将对每个队列分别进行研究终点的统计分析，以便对结果进行特定年龄的评估。本试验的主要目的是评估呼吸暂停氧合是否能预防婴幼儿全身麻醉诱导期间经皮血红蛋白饱和度（SpO₂）下降。主要结局指标将是呼吸暂停期间记录到的最低SpO₂值。
ApOx-Pedi试验已获得当地伦理委员会（德国海德堡大学医学院伦理委员会）的许可，注册号为S-074-2024。该研究遵循机构指南和1975年《赫尔辛基宣言》的最新版本。试验结果将提交给同行评审期刊，并在国内和国际会议上发表。
该试验已在ClinicalTrials.gov上进行前瞻性注册，注册号为NCT06576596。
