Clinical trial NCT04964778: SKED Physiology Study
Official title: A Comparison of Respiratory Status and Comfort of Various Patient Packaging and Transport Configurations on Horizontal Ground
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Comparison of Patient Packaging and Transport Methods
Keywords: SKED
transport configurations
comfort
respiratory status
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Likert Pain Scale
timeFrame: Minute 1
measure: Likert Pain Scale
timeFrame: Minute 5
measure: Borg Dyspnea scale
timeFrame: Minute 1
measure: Borg Dyspnea scale
timeFrame: Minute 5
measure: Change in End-Tidal Carbon Dioxide (ETCO2)
timeFrame: Between baseline and minute 5
measure: Change in Pulse Oximetry
timeFrame: Between baseline and minute 5
measure: Change in Heart Rate
timeFrame: Between baseline and minute 5
measure: Change in Respiratory Rate
timeFrame: Between baseline and minute 5.
measure: Change in Spirometry values for Forced Vital Capacity (FVC)
timeFrame: Between baseline and minute 5
measure: Change in Spirometry values for Forced Expiratory Volume in 6 seconds (FEV6)
timeFrame: Between baseline and minute 5
measure: Change in Spirometry values for Maximal Voluntary Ventilation (MVV)
timeFrame: Between baseline and minute 5
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christopher Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: