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

ConditionAspiration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

● Allergy to local anesthetics, muscle relaxants, sedatives or dexmedetomidine.

History suggestive of intestinal obstruction or gastric outlet obstruction.

Known pregnancy.

Morbid obesity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • gastric ultrasound scan

    Procedure/Surgery

    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).

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: study groupActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

incidance of peri-intubation aspiration

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

Time frame
within 72 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: