Pressure Injury Prevention in AE and PFC
2022年3月1日 更新者：Elizabeth Bridges、University of Washington
Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
This study evaluates the effect of a multilayer skin dressing (Mepilex) placed on the sacrum or a fluid filled pad (LiquiCell) on risk factors for pressure injuries under conditions consistent with military long-distance transport or prolonged field care.
Participants will be assigned to one of six groups - air transport, air transport on a spinal immobilization surface with or without Mepilex or on a field stretcher with or without LiquiCell.
調査の概要
詳細な説明
Combat casualties undergoing long distance aeromedical evacuation (AE), particularly casualties who are immobilized because of possible spine injuries, and casualties who required prolonged field care are at increased risk for pressure injuries.
The risk factors pressure and shear are potentially modifiable via solutions appropriate for these austere conditions.
Two interventions (Mepilex and LiquiCell) will be evaluated under conditions simulating military medical transport on a standard stretcher or with spinal immobilization in a vacuum spine board (VSB) or on a military stretcher used under field conditions.
Mepilex is a multi-layer dressing that can be placed on the skin (sacrum/buttocks) and LiquiCell is a pad filled with pockets of fluid that is placed under the back and buttocks.
The effect of these interventions compared to not using them will be studied under the three conditions with or without the intervention (Mepilex or LiquiCell) using measures obtained on the lower back/sacrum including skin interface pressure, oxygen, moisture, and temperature and a cytokine indicating possible tissue damage.
研究の種類
介入
入学 (実際)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington School of Nursing
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Men and women
- Age 18 to 55
- Meet the physical standards for military personnel
- Weigh less than 250 pounds
- Be able to remain in the study position for the duration of the study.
Exclusion Criteria
- Previous injuries to sacrum/buttocks with scarring
- History of pressure injuries
- Cardiovascular disease
- Neurological disease that would affect vascular response
- Diabetes
- History of malignancy
- Current skin condition (e.g., eczema or psoriasis)
- Current neck/back pain or history of chronic neck/back pain
- Known vertebral/spinal cord disease/injury (scoliosis, kyphosis, or lordosis)
- Self-reported pregnancy
- Concern about ability to remain in the vacuum spine board for 120 minutes
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group 1: Mepilex on Litter + AE Mattress + 30 degree backrest
Intervention: Mepilex
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Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries.
The dressing will be placed on the sacrum.
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介入なし：Group 2: Without Mepilex on Litter + AE mattress + backrest
Intervention: Control (no Mepilex)
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実験的：Group 3: Mepilex on VSB on AE mattress
Intervention: Mepilex
|
Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries.
The dressing will be placed on the sacrum.
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介入なし：Group 4: Without Mepilex on VSB on AE mattress
Intervention: Control (no Mepilex)
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実験的：Group 5 Prolonged Field Care (PFC) - LiquiCell on Talon litter
Intervention: LiquiCell mat
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LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches.
Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up.
LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom.
The overlay is positioned from the shoulders to below the hips to minimize shear.
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介入なし：Group 6: PFC Without LiquiCell on Talon Litter
Intervention: Control (no LiquiCell)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Interleukin-1/Total Protein (Skin)
時間枠：Baseline through study completion - approximately 120 minutes
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Skin cytokine (IL-1) and total protein will be obtained using a small strip of specialized tape placed on the sacrum/buttocks.
After 1-minute application the tape is removed and analyzed for quantity of interleukin-1 (indicator of skin irritation)
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Baseline through study completion - approximately 120 minutes
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Change in Transcutaneous Tissue Oxygen (TcPO2)
時間枠：Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Tissue oxygen is measured continuously on the sacrum using a noninvasive sensor and on the midsternum (midchest) as a control
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Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Change in Skin Moisture (Epidermal and Subepidermal)
時間枠：Baseline (before lying down) and after 120 minutes supine
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Two components of skin moisture will be measured on the sacrum using the Delfin MoistureMeter.
The epidermal moisture, which reflects perspiration and subepidermal moisture , which reflects water content of the tissues.
The values range from 1-80, with higher numbers reflecting increased moisture.
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Baseline (before lying down) and after 120 minutes supine
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Change in Skin Temperature
時間枠：Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Skin temperature will be measured continuously on the sacrum using a laser doppler probe.
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Measured continuously during the baseline (sidelying), supine (120 minutes) and post-sidelying (15 minutes) periods
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Change in Skin Interface Pressure
時間枠：Continuously during the supine phase of the study (120 minutes)
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The pressure between the support surface and the skin will be measured continuously during the supine position using the X Sensor system.
This system measures force/unit area (e.g., pressure).
The peak and average pressure on the sacrum/buttocks will be measured.
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Continuously during the supine phase of the study (120 minutes)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pressure-Discomfort (Category Partitioning Scale-50)
時間枠：The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
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This scale asks the participant to describe in verbal terms the pressure intensity or discomfort associated with the stimulus (i.e., sacral/buttocks pressure or discomfort).
The participant can then fine tune their assessment using a numeric score.
The final score is an analog.
The score ranges from 0-52, with higher scores indicating higher pressure or more severe discomfort.
The investigator will ask the participant to limit their evaluation to the pressure/discomfort sensed on the sacrum/buttocks, but the investigator will also ask the participants to identify on their body where they are experiencing the most pressure/discomfort.
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The score will be obtained at baseline and every 30 minutes in the supine position (total 5 measurements).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Elizabeth Bridges, PhD, RN、University of Washington
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年7月20日
一次修了 (実際)
2020年9月23日
研究の完了 (実際)
2020年9月23日
試験登録日
最初に提出
2019年4月10日
QC基準を満たした最初の提出物
2019年4月19日
最初の投稿 (実際)
2019年4月23日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月16日
QC基準を満たした最後の更新が送信されました
2022年3月1日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00006022
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