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临床试验/NCT05587179
NCT05587179已完成不适用

The Impact of Different Recovery Positions on the Perfusion of the Lower Forearm and Comfort Associated With the Positioning: a Cross-over Randomized Controlled Trial

Centre for Evidence-Based Practice, Belgium2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Cross-sectional area of the ulnar artery (SU) and peak systolic velocity of the ulnar artery (PSVU) of the hand of the dependent arm

研究概览

简要总结

Introduction: A side-lying recovery position is recommended when victims are unresponsive but breathing normally and, hence, do not require cardiopulmonary resuscitation. In 2021, the European Resuscitation Council (ERC) and the Belgian Red Cross-Flanders issued new guidelines which included the description of a modified recovery position to avoid problems in victims with joint stiffness and to overcome potential obstructed venous return in the dependent arm. Based on good practice insights, the dependent arm will now be extended and not bent to support the other arm. However, there is currently no evidence available to support a specific recovery position.

Objectives: The aim of this study is to assess the impact of different recovery positions on perfusion of the forearm and associated comfort.

Methods: In this cross-over randomized controlled trial, 24 healthy volunteers will be placed in either the lateral recovery position with extended dependent arm or with bent arm, and in the other position thereafter. Before and between both recovery positions, the volunteers will be positioned supine for 15 min. Several perfusion indices of the forearm will be non-or mildly invasively monitored in the respective recovery positions by radial artery tonometry, ulnar artery echo doppler and venous congestion plethysmography. Subjective participant's discomfort and pain will be assessed as well. Differences in continuous outcomes between the different recovery positions will be assessed with paired t-tests or wilcoxon signed-rank test.

Discussion: The benefit of lateral positioning of adults and children with decreased level of consciousness has been widely accepted despite limited supportive scientific evidence. We here will provide direct evidence (i) whether venous drainage in the dependent limb is impaired when positioning the victim in the lateral recovery position with bent arms and (ii) whether this potential complication can be minimized by extending the dependent arm. The major limitations of this study is that healthy volunteers, instead of non-responsive victims, are included as participants, and that the study will be performed in a highly controlled environment. Nevertheless, the generated insights will directly fuel evidence-based treatment recommendations regarding the recovery position in first aid settings, and fill a current gap in evidence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers

排除标准

  • History of any coronary or peripheral vascular disease such as Raynaud's disease or thromboangitis obliterans (self-declared)
  • Type I or type II diabetes (self-declared)
  • Intake of cholesterol-lowering medication (self-declared)
  • High blood pressure (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) and/or use of antihypertensive drugs (self-declared)
  • Obesity (BMI > 30 kg/m2)
  • Smoking or using tobacco products (self-declared)

结局指标

主要结局

Cross-sectional area of the ulnar artery (SU) and peak systolic velocity of the ulnar artery (PSVU) of the hand of the dependent arm

时间窗: between 10 to 15 min in each position

measured by echo doppler

Difference in peripheral arterial pressure (PAP)

时间窗: between 10 to 15 min in each position

extracted from pulse wave amplitude (PWA) measured by radial artery tonometry

Peripheral venous pressure (PVP)

时间窗: between 10 to 15 min in each position

measured at the forearm and the back of the hand by venous congestion plethysmography

次要结局

  • Discomfort (experienced by participant)(after 15 min in the recovery position)
  • Oxygen saturation(measured continuously during 1u15 min (15 min supine position, 15 min posture 1, 15 min supine position, 15 min posture 2, 15 min supine position))
  • Heart rate(measured continuously during 1u15min (15 min supine position, 15 min posture 1, 15 min supine position, 15 min posture 2, 15 min supine position))
  • Pain (experienced by participant)(after 15 min in the recovery position)
  • Skin discoloration(after 15 min in the recovery position)

研究者

发起方
Centre for Evidence-Based Practice, Belgium
申办方类型
Other
责任方
Sponsor

研究点 (2)

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