- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07823413
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?
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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).
|
|
Žádný zásah: control group
routine (standard) airway management
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
incidance of peri-intubation aspiration
Časové okno: within 72 hours
|
direct visualization of gastric contents in the oropharynx or airway during laryngoscopy/intubation.
|
within 72 hours
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- GUS Aspiration Prevention
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .