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常规胃残余量测量指导机械通气婴儿和儿童的肠内喂养:GASTRIC 可行性研究。

Routine gastric residual volume measurement to guide enteral feeding in mechanically ventilated infants and children: the GASTRIC feasibility study.

机构信息

School of Health and Society, University of Salford, Salford, UK.

Department of Health Services Research, University of Liverpool, Liverpool, UK.

出版信息

Health Technol Assess. 2020 May;24(23):1-120. doi: 10.3310/hta24230.

Abstract

BACKGROUND

The routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it.

OBJECTIVE

To answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units?

DESIGN

A mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals' opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study.

PARTICIPANTS AND SETTING

Parents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units.

RESULTS

Baseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes were addressed by developing a simple flow chart and education package. The trial design survey and e-Delphi study gained consensus on 12 paediatric intensive care unit and nine neonatal unit outcome measures, and identified acceptable inclusion and exclusion criteria. Given the differences in physiology, disease processes, environments, staffing and outcomes of interest, two different trials are required in the two settings. Database analyses subsequently showed that trials were feasible in both settings in terms of patient numbers. Of 16,222 children who met the inclusion criteria in paediatric intensive care units, 12,629 stayed for > 3 days. In neonatal units, 15,375 neonates < 32 weeks of age met the inclusion criteria. Finally, the two consensus meetings demonstrated 'buy-in' from the wider UK neonatal communities and paediatric intensive care units, and enabled us to discuss and vote on the outcomes that did not achieve consensus in the e-Delphi study.

CONCLUSIONS AND FUTURE WORK

Two separate UK trials (one in neonatal units and one in paediatric intensive care units) are feasible to conduct, but they cannot be combined as a result of differences in outcome measures and treatment protocols, reflecting the distinctness of the two specialties.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN42110505.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 23. See the NIHR Journals Library website for further project information.

摘要

背景

在儿科重症监护病房和新生儿病房中,常规测量胃残留量以指导肠内喂养的启动和输送已广泛应用,但几乎没有支持其应用的基础证据。

目的

回答以下问题:在英国儿科重症监护病房和新生儿病房中,不进行胃残留量测量的试验是否可行?

设计

一项包括五个相互关联的工作包的混合方法研究,分为两个平行的手臂:新生儿病房和儿科重症监护病房。工作包 1:对各单位进行调查,以确定英国目前的实践情况。工作包 2:对入住这两种环境的儿童的医护人员和护理人员进行定性访谈。工作包 3:通过改良的两轮电子德尔菲调查,研究医护人员对试验设计问题的意见,并就结局达成共识。工作包 4:检查国家数据库,以确定潜在的合格人群。工作包 5:两次医护人员和家长的共识会议,审查数据,并就电子德尔菲研究中未达成共识的结局达成共识。

参与者和设置

有通气和管饲经验的新生儿病房和儿科重症监护病房的儿童的家长,以及在新生儿病房和儿科重症监护病房工作的医护人员。

结果

基线调查显示,胃残留量测量的做法非常普遍(儿科重症监护病房为 96%,新生儿病房为 65%)。来自新生儿病房和儿科重症监护病房的 90%的家长都支持未来的试验,同时也强调了对可能延迟发现并发症的担忧。医护人员也表示试验是可行的,84%的工作人员愿意参与试验。初级护士对不测量胃残留量的干预组表示关注,通过制定简单的流程图和教育方案解决了这一问题。试验设计调查和电子德尔菲研究在 12 项儿科重症监护病房和 9 项新生儿病房的结局指标上达成了共识,并确定了可接受的纳入和排除标准。鉴于生理学、疾病过程、环境、人员配备和关注的结果存在差异,这两个环境需要进行两项不同的试验。随后的数据库分析表明,在这两个环境中,从患者数量来看,试验是可行的。在儿科重症监护病房中,符合纳入标准的 16222 名儿童中,有 12629 名儿童住院时间超过 3 天。在新生儿病房中,有 15375 名小于 32 周龄的早产儿符合纳入标准。最后,两次共识会议展示了英国新生儿和儿科重症监护病房的广泛参与,并使我们能够讨论和投票表决电子德尔菲研究中未达成共识的结局。

结论和未来工作

在英国进行两项独立的试验(一项在新生儿病房,一项在儿科重症监护病房)是可行的,但由于结局测量和治疗方案的差异,不能将两者合并,这反映了两个专业的不同性质。

试验注册

当前对照试验 ISRCTN42110505。

资金

本项目由英国国家卫生研究院(NIHR)卫生技术评估计划资助,将全文发表在 ; 第 24 卷,第 23 期。欲了解更多项目信息,请访问 NIHR 期刊库网站。

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