SureCRIC Standardized Patient Study
SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.
Cricothyroid membrane identification accuracy has been reported to be 30-62% in the literature [Bai15, Ell10, Kri15, Lam15]. The current study assesses SureCRIC-assisted medic performance in identifying the cricothyroid membrane in a diverse standardized patient population.
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20008
- National Center for Human Factors in Healthcare
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Participants (Users):
Inclusion Criteria:
- Paramedic or military combat medic
- Trained to perform a cricothyrotomy
Exclusion Criteria:
- Current or former instructor of cricothyrotomy, airway management, or anatomy
- Experience performing cricothyrotomy on a patient in the last 6 months
- Training on cricothyrotomy in the last 3 months
- Previous or current participation in a study related to cricothyrotomy
- Any condition or physical impairment that limits dexterity and/or tactile feedback
- Performed two or more cricothyrotomies on live humans
- Previous exposure to the SureCRIC
Healthy Volunteers (Standardized Patients):
Inclusion Criteria:
- Less than 10th percentile height female
- 50th percentile height female
- Greater than 90th percentile height female
- Less than 10th percentile height male
- 50th percentile height male
- Greater than 90th percentile height male
Exclusion Criteria:
- Previous exposure to the SureCRIC
- Age under 18 or over 60
- Any skin condition including, but not limited to, eczema and hives
- Skin that is thin, fragile, sensitive and/or prone to redness or irritation including skin that maintains a red, irritated appearance after the light application of pressure
- Easy bruising or use of any blood thinning medication (including aspirin)
- Beard on the neck
- Use of a steroid medication by mouth or in a topical formulation like a cream or ointment
- Any of the following chronic conditions: chronic kidney disease, chronic liver disease, coagulation disorders such as hemophilia or von Willebrand disease, low or dysfunctional platelets (e.g., thrombocytopenia), leukemia, Cushing's syndrome, Ehlers Danlos syndrome, celiac disease, any condition that causes easy bruising or sensitive or fragile skin.
- Previous neck surgery, previous neck trauma, thyroid mass or enlargement, or other neck abnormalities
- Any condition that would make lying supine or without a pillow painful or impossible
研究計画
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:処理
- 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 |
|---|---|
|
実験的:SureCRIC
SureCRIC-aided cricothyroid membrane identification
|
SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.
|
|
アクティブコンパレータ:Freehand
Freehand cricothyroid membrane identification
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Freehand palpation approach to identification of the cricothyroid membrane
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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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Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes
時間枠:1 day
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pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
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1 day
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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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Time to Cricothyroid Membrane Identification
時間枠:1 day
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time to cricothyroid membrane identification as measured by direct observation
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1 day
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Bair AE, Chima R. The inaccuracy of using landmark techniques for cricothyroid membrane identification: a comparison of three techniques. Acad Emerg Med. 2015 Aug;22(8):908-14. doi: 10.1111/acem.12732. Epub 2015 Jul 21.
- Elliott DS, Baker PA, Scott MR, Birch CW, Thompson JM. Accuracy of surface landmark identification for cannula cricothyroidotomy. Anaesthesia. 2010 Sep;65(9):889-94. doi: 10.1111/j.1365-2044.2010.06425.x. Erratum In: Anaesthesia. 2010 Dec;65(12):1258.
- Kristensen MS, Teoh WH, Rudolph SS, Tvede MF, Hesselfeldt R, Borglum J, Lohse T, Hansen LN. Structured approach to ultrasound-guided identification of the cricothyroid membrane: a randomized comparison with the palpation method in the morbidly obese. Br J Anaesth. 2015 Jun;114(6):1003-4. doi: 10.1093/bja/aev123. No abstract available.
- Lamb A, Zhang J, Hung O, Flemming B, Mullen T, Bissell MB, Arseneau I. Accuracy of identifying the cricothyroid membrane by anesthesia trainees and staff in a Canadian institution. Can J Anaesth. 2015 May;62(5):495-503. doi: 10.1007/s12630-015-0326-y. Epub 2015 Jan 31.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SureCRIC_SP1
- W81XWH-14-C-0011 (その他の識別子:Defense Health Program)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。