SKED Physiology Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Comparison of Patient Packaging and Transport Methods
• Intervention / Treatment: Device: SKED©

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm1: SKED© only first; 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©; A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.
Experimental: Arm 2: SKED©+Vacuum mattress first; 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©; A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.
Experimental: Arm 3: SKED©+OSS-II© first; 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©; A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.
Experimental: Arm 4: SKED©+foam padding first; 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©; A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Christopher Davis, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: comfort; SKED; transport configurations; respiratory status
• Other Study ID Numbers: IRB00072899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No