Mozun Rebeca, Chopard Daphné, Zapf Florian, Baumann Philipp, Brotschi Barbara, Adam Anika, Jaeggi Vera, Bangerter Beat, Gibbons Kristen S, Burren Juerg, Schlapbach Luregn J
Department of Intensive Care and Neonatology and Children's Research Center, University of Zurich, University Children's Hospital Zürich, Zurich, Zurich, Switzerland
Department of Intensive Care and Neonatology and Children's Research Center, University of Zurich, University Children's Hospital Zürich, Zurich, Zurich, Switzerland.
BMJ Open. 2025 Jan 11;15(1):e087043. doi: 10.1136/bmjopen-2024-087043.
Digital trials are a promising strategy to increase the evidence base for common interventions and may convey considerable efficiency benefits in trial conduct. Although paediatric intensive care units (PICUs) are rich in routine electronic data, highly pragmatic digital trials in this field remain scarce. There are unmet evidence needs for optimal mechanical ventilation modes in paediatric intensive care. We aim to test the feasibility of a digital PICU trial comparing two modes of invasive mechanical ventilation using carbon dioxide (CO) control as the outcome measure.
Single-centre, open-labelled, randomised controlled pilot trial with two parallel treatment arms comparing pressure control versus pressure-regulated volume control. Patients are eligible if aged <18 years, weighing >2 kg, have an arterial line and require >60 min of mechanical ventilation during PICU hospitalisation at the University Children's Hospital Zurich. Exclusion criteria include cardiac shunt lesions, pulmonary hypertension under treatment and intracranial hypertension. CO is measured using three methods: end-tidal (continuous), transcutaneous (continuous) and blood gas analyses (intermittent). Baseline, intervention and outcome data are collected electronically from the patients' routine electronic health records. The primary feasibility outcome is adherence to the assigned ventilation mode, while the primary physiological outcome is the proportion of time spent within the target range of CO (end-tidal, normocarbia defined as CO ≥ 4.5 and ≤ 6 kPa). Both primary outcomes are captured digitally every minute from randomisation until censoring (at 48 hours after randomisation, extubation, discharge or death, whichever comes first). Analysis will occur on an intention-to-treat basis. We aim to enrol 60 patients in total. Recruitment started in January 2024 and continued for 9 months.
This study received ethical approval from the Cantonal Ethics Commission of Zurich (identification number: 2022-00829). Study results will be disseminated through publication in a peer-reviewed journal and other media like podcasts.
NCT05843123.
数字化试验是增加常见干预措施证据基础的一种有前景的策略，并且在试验实施过程中可能带来显著的效率提升。尽管儿科重症监护病房（PICUs）拥有丰富的常规电子数据，但该领域高度实用的数字化试验仍然稀缺。儿科重症监护中对于最佳机械通气模式仍存在未满足的证据需求。我们旨在测试一项数字化PICU试验的可行性，该试验以二氧化碳（CO）控制作为结局指标，比较两种有创机械通气模式。
单中心、开放标签、随机对照试验，设有两个平行治疗组，比较压力控制与压力调节容量控制。年龄小于18岁、体重超过2千克、有动脉置管且在苏黎世大学儿童医院PICU住院期间需要机械通气超过60分钟的患者符合入选条件。排除标准包括心脏分流病变、正在接受治疗的肺动脉高压和颅内高压。使用三种方法测量CO：呼气末（连续）、经皮（连续）和血气分析（间歇）。基线、干预和结局数据从患者的常规电子健康记录中以电子方式收集。主要可行性结局是对指定通气模式的依从性，而主要生理结局是CO在目标范围内的时间比例（呼气末，正常碳酸血症定义为CO≥4.5且≤6kPa）。从随机分组到审查（随机分组后48小时、拔管、出院或死亡，以先发生者为准），每分钟以数字方式记录两个主要结局。分析将基于意向性分析。我们的目标是总共招募60名患者。招募工作于2024年1月开始，持续9个月。
本研究获得了苏黎世州伦理委员会的伦理批准（识别号：2022 - 00829）。研究结果将通过在同行评审期刊上发表以及播客等其他媒体进行传播。
NCT05843123。
