Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation (ITBP)
A Prospective Randomized Crossover Simulation Study Comparing an Integrated Tube-Bougie Prototype With Standard Stilet-Assisted and Gum Elastic Bougie Assisted Endotracheal Intubation
Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device.
This prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence.
The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.
The findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.
調査の概要
状態
詳細な説明
Endotracheal intubation is one of the most commonly performed advanced airway procedures in emergency and critical care. Successful intubation depends not only on adequate visualization of the glottis but also on successful advancement of the endotracheal tube through the vocal cords. Adjunctive devices, such as stylets and elastic bougies, are widely used to facilitate tube placement. However, these devices require additional procedural steps and device exchanges, which may increase procedural complexity and prolong intubation time.
EPATS (Integrated Tube-Bougie Prototype) is a novel airway device developed to integrate the guidance function of an elastic bougie directly into an endotracheal tube. By combining both functions into a single device, EPATS is intended to simplify the intubation process while preserving the advantages of bougie-assisted intubation.
This prospective, randomized, crossover simulation study will evaluate the performance of EPATS compared with conventional elastic bougie-assisted and stylet-assisted endotracheal intubation. Emergency medicine residents will perform endotracheal intubation using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. Before study initiation, all participants will receive standardized training in the use of EPATS and the elastic bougie appropriate to their level of experience. All intubation procedures will be performed under standardized simulation conditions.
The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.
This study will determine whether EPATS improves procedural efficiency and intubation performance compared with conventional intubation adjuncts in a standardized simulation environment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Huseyin Cahit Halhalli, MD
- 電話番号：+902622252700
- メール：huseyin.halhalli@sbu.edu.tr
研究場所
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Kocaeli
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Köseköy、Kocaeli、トルコ（Türkiye）、41060
- University of Health Sciences, Kocaeli City Hospital
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コンタクト：
- Huseyin Cahit Halhalli, MD
- 電話番号：+902622252700
- メール：huseyin.halhalli@sbu.edu.tr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Professional Status: Being an Emergency Medicine Resident actively undergoing specialty training at the University of Health Sciences, Kocaeli City Hospital, Department of Emergency Medicine.
- Voluntary Participation: Voluntarily agreeing to participate in the study and providing written informed consent prior to enrollment.
- Postgraduate year (PGY) 1-4 residents.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Refusal to Participate: Declining to participate or refusing to provide written informed consent.
- Physical or Neurological Limitations: Having any pre-existing physical, motor, or neurological impairment that could interfere with manual dexterity, procedural performance, or airway management simulation (e.g., hand injuries, tremors, etc.).
- Inability to complete all study procedures.
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：クロスオーバー割り当て
- マスキング：独身
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：EPATS
Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios.
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The novel integrated tube-bougie prototype developed for endotracheal intubation.
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アクティブコンパレータ：Standard Gum Elastic Bougie
Participants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios.
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Standard gum elastic bougie used as an intubation adjunct.
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アクティブコンパレータ：Standard Stylet
Participants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios.
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Standard intubating stylet used as an intubation adjunct.
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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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Time to successful endotracheal intubation
時間枠：During the study procedure
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The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.
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During the study procedure
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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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First Pass Success (FPS)
時間枠：During the study procedure
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Successful endotracheal intubation without removing the laryngoscope from the mouth.
Attempts exceeding 60 seconds will be considered unsuccessful.
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During the study procedure
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Difficulty Assessment (VAS)
時間枠：At the end of the study procedure
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The practitioner's difficulty perception will be measured using a 0-100 mm visual analog scale.
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At the end of the study procedure
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Complications (Dental trauma and Esophageal intubation)
時間枠：During the study procedure
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Complications for each procedure (dental trauma and esophageal intubation) will be determined by the researchers.
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During the study procedure
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Learning Curve (CUSUM)
時間枠：During the study procedure
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For each participant, success/failure data will be used for analysis; this analysis will be considered exploratory.
The number of endotracheal intubation attempts required to learn will be recorded in the data collection.
Sequential intubation performance data will be analyzed using cumulative sum (CUSUM) analysis.
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During the study procedure
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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