SKED Physiology Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison of Respiratory Status and Comfort of Various Patient Packaging and Transport Configurations on Horizontal Ground

Conditions
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Comparison of Patient Packaging and Transport Methods

Intervention / Treatment
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* Device: SKED©


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will be packaged with SKED© only; SKED©+OSS-II©; SKED©+Vacuum mattress; SKED©+foam padding. Each arm will consist of the same interventions in a specified, but unique order. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1: SKED© only first<br>Each participant will be packaged using a SKED© system with no assumed spinal injury. Each arm will consist of the same interventions in a specified, but unique order. Arm 1 will be in the following order: SKED© only; SKED©+OSS-II©; SKED©+Vacuum mattress; SKED©+foam padding | Device: SKED©<br>* A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.<br>|
| Experimental: Arm 2: SKED©+Vacuum mattress first<br>Each participant will be packaged using a SKED© system with no assumed spinal injury. Each arm will consist of the same interventions in a specified, but unique order. Arm 2 will be in the following order: SKED©+Vacuum mattress; SKED©+OSS-II©; SKED©+foam padding, SKED© only | Device: SKED©<br>* A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.<br>|
| Experimental: Arm 3: SKED©+OSS-II© first<br>Each participant will be packaged using a SKED© system with no assumed spinal injury. Each arm will consist of the same interventions in a specified, but unique order. Arm 3 will be in the following order: SKED©+OSS-II©;SKED©+Vacuum mattress; SKED© only; SKED©+foam padding | Device: SKED©<br>* A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.<br>|
| Experimental: Arm 4: SKED©+foam padding first<br>Each participant will be packaged using a SKED© system with no assumed spinal injury. Each arm will consist of the same interventions in a specified, but unique order. Arm 4 will be in the following order: SKED©+foam padding, SKED©+Vacuum mattress; SKED© only; SKED©+OSS-II | Device: SKED©<br>* A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert Pain Scale | Score ranges from 0-10 with a higher score denoting more pain. | Minute 1 | 
| Likert Pain Scale | Score ranges from 0-10 with a higher score denoting more pain. | Minute 5 | 
| Borg Dyspnea scale | Measures difficulty breathing. Score ranges from 0-10 with higher score denoting more breathlessness. | Minute 1 | 
| Borg Dyspnea scale | Measures difficulty breathing. Score ranges from 0-10 with higher score denoting more breathlessness. | Minute 5 | 
| Change in End-Tidal Carbon Dioxide (ETCO2) | Change in measurement from baseline. | Between baseline and minute 5 | 
| Change in Pulse Oximetry | Test used to measure the oxygen level (oxygen saturation) of the blood. Oximetry will be compared between interventions and baseline. | Between baseline and minute 5 | 
| Change in Heart Rate | Change in beats per minute from baseline | Between baseline and minute 5 | 
| Change in Respiratory Rate | Change in breaths per minute from baseline. | Between baseline and minute 5. | 
| Change in Spirometry values for Forced Vital Capacity (FVC) | FVC is the maximum amount of air a person can expel from the lungs after a maximum inhalation. Change in FVC from baseline. | Between baseline and minute 5 | 
| Change in Spirometry values for Forced Expiratory Volume in 6 seconds (FEV6) | FEV6 is the volume of air forcefully exhaled after 6 seconds. Change in FEV6 from baseline. | Between baseline and minute 5 | 
| Change in Spirometry values for Maximal Voluntary Ventilation (MVV) | 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. | Between baseline and minute 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SKED, transport configurations, comfort, respiratory status