SKED Physiology Study

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Comparison of Patient Packaging and Transport Methods

Treatments: Device: SKED©

Study type: Interventional

Funder types: Other

Identifiers

NCT04964778

IRB00072899

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Arm1: SKED© only first

Experimental group

Description:

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

Treatment:

Device: SKED©

Arm 2: SKED©+Vacuum mattress first

Experimental group

Description:

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

Treatment:

Device: SKED©

Arm 3: SKED©+OSS-II© first

Experimental group

Description:

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

Treatment:

Device: SKED©

Arm 4: SKED©+foam padding first

Experimental group

Description:

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

Treatment:

Device: SKED©