Chen Jiaxiang, Lin Rongmu, Shi Xiaoli, Liang Changsheng, Hu Wei, Ma Xinggang, Xu Liang
Department of Anaesthesiology, Shenzhen Children's Hospital, Shenzhen, Guangdong, China.
Department of Anaesthesiology, Shenzhen Paediatrics Institute of Shantou University Medical College, Shenzhen, China.
BMJ Paediatr Open. 2024 Jul 16;8(1):e002359. doi: 10.1136/bmjpo-2023-002359.
Lung-protective ventilation strategies (LPVS) for one-lung ventilation (OLV) in paediatric patients pose greater challenges than in adults. Optimising LPVS for paediatric OLV to mitigate postoperative pulmonary complications (PPCs) has emerged as a current research focal point. However, there remains a divergence of opinions concerning the individualised setting and application of positive end-expiratory pressure (PEEP). Lung dynamic compliance (Cdyn) can serve as a reflection of the lung's physiological state in children during OLV and is a readily obtainable parameter. This study protocol is formulated to assess the effectiveness of Cdyn-guided PEEP titration on PPCs during paediatric OLV.
This study constitutes a single-centre, prospective, double-blind, randomised controlled trial. The trial aims to recruit 60 paediatric patients scheduled for video-assisted thoracoscopic surgery. These eligible patients will be randomly assigned to either the Cdyn-guided PEEP group or the conventional PEEP group during general anaesthesia for OLV. The primary outcome will involve assessing the incidence of PPCs at 7 days after surgery. Secondary outcomes will encompass the evaluation of the modified lung ultrasound score following surgery, as well as monitoring the oxygenation index, driving pressure and Cdyn during mechanical ventilation. Data collection will be performed by investigators who are kept blinded to the interventions.
The Clinical Trial Ethics Committee at Shenzhen Children's Hospital has conferred ethical approvals for this trial (approval number: 2022076). Results from this trial will be disseminated in peer-reviewed journals and presented at professional symposiums.
NCT05386901.
小儿患者单肺通气（OLV）的肺保护性通气策略（LPVS）比成人面临更大挑战。优化小儿OLV的LPVS以减轻术后肺部并发症（PPCs）已成为当前研究的焦点。然而，关于呼气末正压（PEEP）的个体化设置和应用仍存在意见分歧。肺动态顺应性（Cdyn）可反映小儿OLV期间肺的生理状态，且是一个易于获取的参数。本研究方案旨在评估Cdyn指导的PEEP滴定对小儿OLV期间PPCs的有效性。
本研究为单中心、前瞻性、双盲、随机对照试验。试验旨在招募60例计划行电视辅助胸腔镜手术的小儿患者。这些符合条件的患者在全身麻醉下行OLV时将被随机分配至Cdyn指导的PEEP组或传统PEEP组。主要结局将包括评估术后7天PPCs的发生率。次要结局将包括评估术后改良肺超声评分，以及监测机械通气期间的氧合指数、驱动压力和Cdyn。数据收集将由对干预措施不知情的研究人员进行。
深圳市儿童医院临床试验伦理委员会已批准本试验（批准号：2022076）。本试验结果将在同行评审期刊上发表，并在专业研讨会上展示。
NCT05386901。
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