Protocol for a feasibility randomised controlled trial of administering daytime only enteral feeding compared to standard continuous enteral feeding, to reduce delirium in mechanically ventilated, critically ill adults, with qualitative and circadian mechanistic sub-studies.

IF 1.9 Q3 CRITICAL CARE MEDICINE
Jessie Welbourne, Helen Neilens, Liesl Wandrag, Rachel Clarke, Helen McKenna, Liana Stapleton, Ahilanandan Dushianthan, Kat Tapson, Tim Macdonald, Elis Wilson, Helen Hambly, Sree Aroori, Paigan Aspinall, Chris Rollinson, Victoria Allgar, Daniel Martin
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引用次数: 0

Abstract

Background: Survivors of critical illness describe delirium as a significant problem. Delirium is multi-factorial in origin and known to be associated with disrupted circadian rhythms. The timing of enteral feeding contributes to circadian rhythms. We hypothesised that the normal practice of providing continuous enteral nutrition during critical illness may contribute to delirium, due to the adverse effects on circadian rhythms.

Methods: DAYDREAM is a multicentre, open-label, randomised controlled feasibility trial conducted in two UK ICUs. Forty mechanically ventilated adult patients requiring enteral nutrition will be randomised 1:1 to receive either daytime-only feeding (08:00-22:00) or standard continuous enteral feeding. The primary outcomes are feasibility metrics, including recruitment, retention, intervention fidelity, and completeness of data collection. Secondary outcomes include delirium- and coma-free days (assessed using RASS and CAM-ICU), feeding intolerance, glycaemic control, ICU length of stay, and 90-day mortality. A nested qualitative sub-study will explore staff acceptability and implementation barriers. A mechanistic sub-study will evaluate circadian rhythmicity using physiological and biochemical markers between days 3 and 5 of ICU admission.

Results: Recruitment commenced in December 2025, with completion anticipated in 2027. Findings will inform the design and delivery of a subsequent definitive multicentre trial.

Conclusion: This study will determine the feasibility of implementing daytime-only enteral feeding in critically ill adults and provide preliminary data on its clinical and circadian effects.

一项可行性随机对照试验方案,与标准连续肠内喂养相比,仅给予日间肠内喂养,以减少机械通气危重患者谵妄,并进行定性和昼夜节律机制子研究。
背景:危重疾病幸存者将谵妄描述为一个重要问题。谵妄的起源是多因素的,已知与昼夜节律紊乱有关。肠内喂养的时间决定了昼夜节律。我们假设在危重疾病期间提供持续肠内营养的正常做法可能会导致谵妄,因为对昼夜节律有不利影响。DAYDREAM是一项多中心、开放标签、随机对照可行性试验,在两个英国icu中进行。40例需要肠内营养的机械通气成年患者将按1:1随机分组,接受白天纯喂养(08:00-22:00)或标准连续肠内喂养。主要结果是可行性指标,包括招募、保留、干预保真度和数据收集的完整性。次要结局包括谵妄和无昏迷天数(使用RASS和CAM-ICU评估)、喂养不耐受、血糖控制、ICU住院时间和90天死亡率。一个嵌套的定性子研究将探讨员工的可接受性和实施障碍。一项机械性的子研究将使用ICU入院第3至5天的生理生化指标评估昼夜节律。结果:招聘于2025年12月开始,预计于2027年完成。研究结果将为随后确定的多中心试验的设计和交付提供信息。结论:本研究将确定在危重症成人中实施日间纯肠内喂养的可行性,并提供其临床和昼夜节律效应的初步数据。
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来源期刊
Journal of the Intensive Care Society
Journal of the Intensive Care Society Nursing-Critical Care Nursing
CiteScore
4.40
自引率
0.00%
发文量
45
期刊介绍: The Journal of the Intensive Care Society (JICS) is an international, peer-reviewed journal that strives to disseminate clinically and scientifically relevant peer-reviewed research, evaluation, experience and opinion to all staff working in the field of intensive care medicine. Our aim is to inform clinicians on the provision of best practice and provide direction for innovative scientific research in what is one of the broadest and most multi-disciplinary healthcare specialties. While original articles and systematic reviews lie at the heart of the Journal, we also value and recognise the need for opinion articles, case reports and correspondence to guide clinically and scientifically important areas in which conclusive evidence is lacking. The style of the Journal is based on its founding mission statement to ‘instruct, inform and entertain by encompassing the best aspects of both tabloid and broadsheet''.
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