SKED Physiology Study
- Conditions
- Comparison of Patient Packaging and Transport Methods
- Interventions
- Device: SKED©
- Registration Number
- NCT04964778
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Healthy adults
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm1: SKED© only first SKED© 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 Arm 2: SKED©+Vacuum mattress first SKED© 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 Arm 3: SKED©+OSS-II© first SKED© 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 Arm 4: SKED©+foam padding first SKED© 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
- Primary Outcome Measures
Name Time Method Change in Heart Rate Between baseline and minute 5 Change in beats per minute from baseline
Change in Respiratory Rate Between baseline and minute 5. Change in breaths per minute from baseline.
Change in Spirometry values for Maximal Voluntary Ventilation (MVV) 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 Minute 5 Score ranges from 0-10 with a higher score denoting more pain.
Change in End-Tidal Carbon Dioxide (ETCO2) Between baseline and minute 5 Change in measurement from baseline.
Change in Spirometry values for Forced Vital Capacity (FVC) 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) Between baseline and minute 5 FEV6 is the volume of air forcefully exhaled after 6 seconds. Change in FEV6 from baseline.
Borg Dyspnea scale Minute 5 Measures difficulty breathing. Score ranges from 0-10 with higher score denoting more breathlessness.
Change in Pulse Oximetry 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States