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SKED Physiology Study

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04964778
Enrollment
0
Registered
2021-07-16
Start date
2023-08-31
Completion date
2024-01-31
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of Patient Packaging and Transport Methods

Keywords

SKED, transport configurations, comfort, respiratory status

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.

Interventions

DEVICESKED©

A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Likert Pain ScaleMinute 1Score ranges from 0-10 with a higher score denoting more pain.
Borg Dyspnea scaleMinute 1Measures difficulty breathing. Score ranges from 0-10 with higher score denoting more breathlessness.
Change in End-Tidal Carbon Dioxide (ETCO2)Between baseline and minute 5Change in measurement from baseline.
Change in Pulse OximetryBetween baseline and minute 5Test used to measure the oxygen level (oxygen saturation) of the blood. Oximetry will be compared between interventions and baseline.
Change in Heart RateBetween baseline and minute 5Change in beats per minute from baseline
Change in Respiratory RateBetween baseline and minute 5.Change in breaths per minute from baseline.
Change in Spirometry values for Forced Vital Capacity (FVC)Between baseline and minute 5FVC 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 5FEV6 is the volume of air forcefully exhaled after 6 seconds. Change in FEV6 from baseline.
Change in Spirometry values for Maximal Voluntary Ventilation (MVV)Between baseline and minute 5MVV 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026