Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury

NCT ID: NCT03317288

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2019-03-31

Brief Summary

The purpose of this study is to test if the newly-developed Dabir alternating pressure (AP) overlay could be beneficial to preventing skin damage during daily activities, such as lying in bed. Specifically, the study is being done to test if the Dabir AP overlay could be used to increase skin tolerance when lying in bed for an extended period of time (40 minutes), including reducing pressure and increasing skin blood flow (amount of blood supply to oxygen and nutrients to skin) as compared to regular operation room (OR) overlay.

A total of 20 participants with spinal cord injury will be recruited. Subjects will undergo study procedures including: AP and Control protocols. Skin blood flow and interface pressure will be collected non-invasively (from outside the body) during both protocols. During AP protocols, subject will be asked to lie on side (10 min), on back on AP overlay (40 min), on side (30 min), on back on OR overlay (40 min), and on side (10 min). During Control protocol, subject will be asked to lie on side (10 min), on back on OR overlay (40 min), and on side (10 min). Subject will then proceed to vascular control measures, including: non-invasive skin blood flow and tissue oxygen measurements with mild heating and electrical stimulation. Findings from this study will help us understand the effectiveness of the AP overlay on skin blood flow response during prolonged lying in bed.

Detailed Description

Tissue ischemia is one of the main etiologies of pressure injury. It is inevitable during bed-ridden and wheelchair bound conditions, such as spinal cord injury (SCI), or prolonged surgery procedure in the operating room. Active alternating pressure (AP) mattresses are covered by Medicare policy for patients with multiple/large stage 2/ stage 3 pressure injuries to relief interface pressure and prevent recurrence of pressure injuries. Previous studies demonstrated that the protective mechanisms of AP on pressure injury include redistribution of surface pressure, and allowing more blood supplies while lying on the support surface. The Dabir AP overlay is low profile yet possesses similar characteristics as other AP mattresses on the market; it is intended for clinical use, such as operation room (OR) where AP mattresses may not be an option. We expect Dabir AP overlay will be beneficial to people at risk of pressure injury by maintaining the blood supply during weight bearing condition.

The objective of this study is to evaluate the protective mechanisms of Dabir AP overlay on weight bearing tissue of people with chronic spinal cord injury (SCI). Our central hypothesis is that the Dabir AP overlay will cause lower amount of interface pressure and allow more skin blood flow during weight bearing as compared to regular OR overlay.

Each subject will undergo two study protocols: AP and control, and the order of the protocols will be randomized by drawing one envelope from the envelope pool. We will start with a pool of total 20 envelopes (10 envelopes indicating AP protocol first, and 10 envelopes indicating control protocol first). A 30-minute washout period will be provided in between the two protocols. Two Laser Doppler flowmetry (LDF) flat probes (moor instrument, Wilmington, DE) will be taped to the sacrum and one heel to collect the skin blood flow response throughout both AP and control protocols. A whole body pressure mapping system will be used between the subject and the overlay to collect the inter pressure data. For the AP cycle, we will use four 10-minute cycles (5 minutes of high pressure and 5 minutes of low pressure).

AP protocol: The subject will first lie on his/her side quietly for 10 minutes to collect the baseline skin blood flow, followed by lying supine on the Dabir AP overlay for 40 minutes, and then side lying for 30 minutes to collect the first reactive hyperemic response. To test the effect of preconditioning, the subject will then lie supine on the OR overlay for 40 minutes followed by side lying for 30 minutes for the second reactive hyperemic response.

Control protocol: The subject will first lie on his/her side quietly for 10 minutes to collect the baseline skin blood flow, followed by lying supine on the OR overlay for 40 minutes, and then side lying for 30 minutes to collect the reactive hyperemic response for control protocol.

The PI, or key personnel will then collect the vascular control measures, including the heat hyperemic (HH) blood flow response, and the skin vasomotor response. A non-invasive combined laser Doppler and white light reflectance spectroscopy (LDF-WLRS) probe (CP2T-1000, Moor Instrument, Wilmington, DE) will be used for both measures.

HH blood flow response will be measured at the sacrum and one heel while the subject is in side-lying position. HH will be induced with the heater at the tip of the probe head (41°C for 5 minutes). This HH measure will take approximately 7 minutes (2 min-baseline, 5 min-heating) per location. In total, the HH measures will take up to 15 minutes to complete.

The skin vasomotor response will be induced using cutaneous electrical stimulation (3-10 mA, 0.2-1.0 ms pulses at 20 Hz, 1 s trains) delivered via 1 cm Ag-AgCl surface electrodes applied bilaterally (4 cm apart) to the forehead (above lesion) and the abdominal wall (below lesion) while the subject is in a semi-reclined position.12 For each site, 5-8 stimuli will be delivered randomly. CP2T-1000 probe will be used to collect SBF and tissue oxygenation data at pulp of the second finger and toe. Subject will be in a semi-reclined position (about 30° from horizontal plane) during this protocol, and it will take up to 15 minutes to complete this protocol.

Pressure mapping of wheelchair: (approximately 10 minutes) The subject will be asked to transfer back to his/her wheelchair with the pressure mapping system placed between the wheelchair and the subject to collect the interface pressure data. The pressure mapping system is the same as that used between the subject and overlay to collect the interface pressure data.

Conditions

Spinal Cord Injuries; Pressure Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SCI subjects

The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay.

Group Type: OTHER

Dabir Air overlay

Intervention Type: DEVICE

The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.

Interventions

Dabir Air overlay

The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• have had spinal cord injury for more than one year
• have injury level at T10 or above
• not ambulatory and use a wheelchair for mobility
• none smokers or able to refrain from smoking four hours prior to and during the study

Exclusion Criteria

• current pressure ulcer
• history of diabetes mellitus
• history of cardiovascular diseases
• history of hypertension
• history of pulmonary diseases
• pregnant women (based on a positive pregnancy test)
• Non-English speakers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dabir Surfaces Inc

INDUSTRY

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Yi-Ting Tzen

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-Ting Tzen, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-0215

Identifier Type: -

Identifier Source: org_study_id