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临床试验/NCT07219290
NCT07219290Enrolling By Invitation不适用

Pulmonary Function by Litter Position

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
12
试验地点
1
主要终点
Forced Vital Capacity

研究概览

简要总结

A litter is often needed to extract a person from an austere environment like the wilderness or from confined, urban spaces. A horizontal litter is generally assumed to be better for patient care, but often makes for a more difficult, if not impossible, evacuation from some settings such as confined space rescue, cave rescue, or wilderness rescue when the litter must be moved up or down a cliff with an undercut edge. A litter in a vertical orientation is easier to move in these situations, which may expedite movement towards definitive care. In some wilderness rescue circles, the mantra is that movement IS definitive care. It is already known that lying flat on the ground negatively affects pulmonary function compared to a sitting baseline.1 It is possible that a vertically oriented litter is better for a subset of patients with respiratory issues than a horizontal litter. The investigators hypothesize that pulmonary function measured by FEV1, FVC, and FEV1/FVC, is better in simulated patients in a vertically oriented litter compared to a horizontally oriented one.

详细描述

Objective To quantify changes in pulmonary function tests (PFTs) based on litter position.

Hypotheses:

  • Compared to sitting baseline, all PFTs in the litter will have decreased forced vital capacity (FVC) and 1 second forced expiratory volume (FEV1).
  • Compared to lying down, persons straight upright and pitched forward will have better forced vital capacity (FVC) and 1 second forced expiratory volume (FEV1).
  • We do not hypothesize any changes in FEV1/FVC.

Study Design This randomized crossover study will use twelve healthy volunteers. All subjects will do baseline sitting pulmonary testing. Experimental order is balanced to avoid any training effects. Choice of sequence will be by random selection of envelope.

Methods Once consented, included subjects will do baseline sitting measurement of FEV1 and FVC which will give FEV1/FVC. Each subject will then be secured in a Ferno-Washington Model 71 litter wearing their own type 2 or 3 harness, or in a UL tested CMC ATOM Global Harness (California Mountain Corporation, Santa Barbara, CA) meeting ANSI Z359.11-2014 and NFPA 1983-2017 standards, if they don't have their own. The person will be secured with double Vs from the litter sides to the harness and footloops supporting them so their weight is on their feet and only minimally on the harness (if vertical). This process is consistent with industry standards for securing a patient in the litter and follows the specific model of the National Cave Rescue Commission.3 See figure 1 Prior to being secured in the litter the patient will do sitting baseline FEV1 and FVC with an NDDD spirograph. Once there is baseline data the subject will be secured in the litter. The investigators will then repeat spirometry, pulse, and blood pressure in a horizontal position (see figure 2), in a vertical position (see figure 3), and pitched slightly forward in a position that results from a Pike and Pivot rigging for raising up past a difficult cliff edge (see figure 4). The subject will get a rest period in their preferred position until pulse returns to within 5 beats of baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

  • 130-310 pounds

排除标准

  • Significant cardiac or pulmonary diseae

研究组 & 干预措施

Flat

Active Comparator

Secured in a flat litter

干预措施: LItter position PFTs (Other)

Vertical

Active Comparator

Secured in a vertical litter

干预措施: LItter position PFTs (Other)

Pitched forward

Active Comparator

Secured in a litter leaning forward

干预措施: LItter position PFTs (Other)

Baseline

Placebo Comparator

Sitting baseline pulmonary function

干预措施: LItter position PFTs (Other)

结局指标

主要结局

Forced Vital Capacity

时间窗: Immediately

Measurable lung volume on expiration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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