A Comparison of Respiratory Status and Comfort of Various Patient Packaging and Transport Configurations on Horizontal Ground
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Heart Rate
研究概览
简要总结
A SKED© is a stretcher typically used for for confined space, high angle, or technical rescue. SKED© is not an acronym; the word came from fusing two words: "Sled" and "Skid." Over the last several years, as recommendations for spinal protection and utilization of adjunct field hardware for patient application changes, there have been conflicting training and practice regarding optimizing patient packaging utilizing the SKED© system. Specifically, there is disagreement in terms of optimal packaging to ensure no decompensation of respiratory status of the patient objectively, as well as comfort level subjectively solely related to the packaging method utilized. Several training bodies currently employ different practices of packaging including use of an Oregon Spine Splint-II© (OSS-II) system within a SKED©, foam padding, vacuum mattress configuration, or even no additional adjunct at all. The objective of this study is to determine whether adjuncts to the SKED© system impact respiratory physiology, or patient comfort while being dragged over horizontal ground.
详细描述
This study will be a randomized controlled, non-blinded trial The setting of this study will be an area of level ground, outdoors at a state park. Study enrollment goal is 50 subjects. This was determined by review of statistics from similar studies, available funding and time frame allocated to complete the study. There is not planned interim analysis, and no criteria for ending the study early. Each participant will be packaged using a SKED© system with no assumed spinal injury. Each subject will be packaged with SKED© only; SKED©+OSS-II©; SKED©+Vacuum mattress; SKED©+foam padding. Each patient packaged within their respective systems as one unit will be subject to a 30 meter controlled drag over terrain chosen to mimic a standard dry backcountry extrication drag. Then carried back to the start by a 4 person carry team to simulate a carry out scenario. The same 30 meter ground area will be used for all systems. Built in safety during the drag includes a manually monitored electric winch system with load cells and two safety operators walking alongside the packaged patient. Target movement will be approximately 1.5-2 miles per hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Healthy adults
排除标准
- •Pregnant females
- •Incarcerated individuals
- •Anyone with difficulty with enclosed or restrictive spaces
- •Subjects with a history of lung disease such as Chronic obstructive pulmonary disease (COPD) or asthma
结局指标
主要结局
Change in Heart Rate
时间窗: Between baseline and minute 5
Change in beats per minute from baseline
Change in Respiratory Rate
时间窗: Between baseline and minute 5.
Change in breaths per minute from baseline.
Change in Spirometry values for Maximal Voluntary Ventilation (MVV)
时间窗: Between baseline and minute 5
MVV is a spirometry test that measures the. largest volume that can be moved into and out of the lungs during a 10-15 second interval with voluntary effort. Change in MVV from baseline.
Likert Pain Scale
时间窗: Minute 5
Score ranges from 0-10 with a higher score denoting more pain.
Change in End-Tidal Carbon Dioxide (ETCO2)
时间窗: Between baseline and minute 5
Change in measurement from baseline.
Change in Spirometry values for Forced Vital Capacity (FVC)
时间窗: Between baseline and minute 5
FVC is the maximum amount of air a person can expel from the lungs after a maximum inhalation. Change in FVC from baseline.
Change in Spirometry values for Forced Expiratory Volume in 6 seconds (FEV6)
时间窗: Between baseline and minute 5
FEV6 is the volume of air forcefully exhaled after 6 seconds. Change in FEV6 from baseline.
Borg Dyspnea scale
时间窗: Minute 5
Measures difficulty breathing. Score ranges from 0-10 with higher score denoting more breathlessness.
Change in Pulse Oximetry
时间窗: Between baseline and minute 5
Test used to measure the oxygen level (oxygen saturation) of the blood. Oximetry will be compared between interventions and baseline.
次要结局
未报告次要终点