Airway Bundle With Gastric Ultrasound Guidance for Aspiration Prevention During Emergency Intubation in Assiut University Hospital.
Emergency endotracheal intubation is a high-risk procedure performed frequently in critically ill patients, with major complications, including pulmonary aspiration, reported across a substantial proportion of cases (1). Reported aspiration incidence after ED intubation varies widely with definition and case-mix, from as low as 3.5% in early retrospective series (2) up to 22% in trauma-heavy cohorts (3). Aspiration pneumonia specifically has been documented in roughly 8% of contemporary prospective ED intubation cohorts (4), and failure on the first intubation attempt is independently associated with a higher likelihood of aspiration and other adverse events (5).
Aspiration is one of the must-pay-attention-to risk factors in patients undergoing endotracheal intubation due to its linked mortality and morbidity (6). The induction and paralytic agents used in endotracheal intubation weaken the protective airway reflexes and the lower esophageal sphincter tone that can lead to aspiration of the gastric content (6).
Point-of-care gastric ultrasound (GUS) has been a reliable tool to assess gastric content preoperatively and in the Emergency Department (7). Previous studies mentioned the use of GUS as a qualitative tool (Perlas criteria) and as a quantitative tool using the Cross-Sectional Area of the Antrum (CSA) in the supine and right lateral decubitus (RLD) positions (7,8). CSA can be calculated by a known formula, CSA = (AP × CC) x π/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter (7). Gastric volume can be calculated with CSA and the age of the patient using the Perlas formula, GV = 27.0 + (14.6 × CSA) - (1.28 × Age) (7). The Perlas formula applies only to non-pregnant adults whose BMI is less than 40 (8). The Perlas grading system and CSA-based volume model have subsequently been validated against gastroscopically-suctioned gastric volumes in adult surgical patients (9), and combining the qualitative grade with the CSA-derived volume has been shown to sharply improve discrimination of a full stomach, with a pre-test probability of 50% rising to roughly 98% following a positive scan (10). GUS has multiple studies assessing its diagnostic accuracy and its association to aspiration (11); nevertheless, it hasn't been studied as a guide to the airway management of patients with the risk of aspiration undergoing endotracheal intubation.
The present trial asks the next question: among ED trauma patients found to have a high risk of aspiration during endotracheal intubation, does a focused, low-resource bundle lower the rate of aspiration, compared with standard unstructured practice?
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
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:
- aged ≥ 18 years, presenting to the ED with a trauma-related indication and requiring urgent or semi-urgent endotracheal intubation, as determined by the treating emergency physician.
Exclusion Criteria:
● Allergy to local anesthetics, muscle relaxants, sedatives or dexmedetomidine.
- History suggestive of intestinal obstruction or gastric outlet obstruction.
- Known pregnancy.
- Morbid obesity.
- History of gastric/esophageal surgery.
- Gastroesophageal reflux disease (GERD), or any other pathology affecting the physiology or function of the gastrointestinal tract or the lower esophageal sphincter (LES).
- Patients in cardiac or respiratory arrest or any patients requiring crash intubation.
- Patients with a gastric or duodenal tube in situ.
- Anticipated difficult airway for reasons unrelated to aspiration risk (e.g., known airway tumor), where bundle elements would be superseded by a dedicated difficult-airway protocol.
- Patients with vertebral and spinal trauma.
- Clinically evident aspiration prior to gastric ultrasound assessment (e.g., witnessed aspiration before ED arrival).
- Anticipated interval between the gastric ultrasound scan and induction exceeding 30 minutes, where a significant change in gastric content cannot be excluded.
- Patients/guardians not consenting to take part in the study.
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:防止
- 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 |
|---|---|
|
アクティブコンパレータ:study group
Gastric ultrasound scan
|
A low-frequency curvilinear probe is used.
The patient is scanned in the right lateral decubitus position (or supine, if positioning is limited - for example, due to spinal precautions).
|
|
介入なし:control group
routine (standard) airway management
|
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 |
|---|---|---|
|
incidance of peri-intubation aspiration
時間枠:within 72 hours
|
direct visualization of gastric contents in the oropharynx or airway during laryngoscopy/intubation.
|
within 72 hours
|
協力者と研究者
スポンサー
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
その他の研究ID番号
- GUS Aspiration Prevention
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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