Airway Bundle With Gastric Ultrasound Guidance for Aspiration Prevention During Emergency Intubation in Assiut University Hospital.

NCT07823413 | Not Yet Recruiting DMC

• 1 other identifier: GUS Aspiration Prevention
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Aspiration

Outcome Measures

Primary Outcomes (1)

• incidance of peri-intubation aspiration

  direct visualization of gastric contents in the oropharynx or airway during laryngoscopy/intubation.

  within 72 hours

Study Arms (2)

study group

ACTIVE COMPARATOR

Gastric ultrasound scan

Procedure: gastric ultrasound scan

control group

NO INTERVENTION

routine (standard) airway management

Interventions

gastric ultrasound scan PROCEDURE

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).

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09