Gastric POCUS for Airway Management in Patients Using Glucagon-like Peptide-1 Receptor Agonist (Multicentric)

NCT06666049 | Recruiting

• 1 other identifier: POCUS
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

1\. Introduction Scheduled surgery requires patients to undergo a preoperative fasting period of at least 6 hours to reduce the risk of perioperative pulmonary aspiration. However, certain medications and conditions may delay gastric emptying, potentially increasing aspiration risk. These include diabetic gastroparesis and the use of glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity. GLP-1 receptor agonists are widely used due to their beneficial effects on glycemic control and weight reduction. However, one of their known effects is delayed gastric emptying, which may result in increased residual gastric content despite adherence to standard fasting guidelines. Recent reports have described cases of pulmonary aspiration during anesthesia in patients receiving GLP-1 receptor agonists, even after appropriate fasting. Given the increasing use of these medications, there is a need for objective assessment tools to evaluate gastric content in the perioperative setting. Gastric ultrasonography has emerged as a non-invasive bedside technique that may help identify patients at increased risk of aspiration and guide airway management strategies.

Conditions

Aspiration Pneumonia

Keywords

Bronchopulmonary complications; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Gastric Ultrasound

  Gastric ultrasonography performed by trained anesthesiologists, for measuring gastric content in volume (cm3) is a useful tool for assessing gastric content and making clinical decisions regarding airway management.

  Immediately prior to induction of anesthesia

Secondary Outcomes (3)

• weight in kilograms

  Immediately prior to induction of anesthesia

• Height in centimeters

  Immediately prior to induction of anesthesia

• BMI in kg/m^2

  Immediately prior to induction of anesthesia

Study Arms (1)

Treatment with GLP-1 agonists

Patients undergoing treatment with GLP-1 agonists, from any geographical area, who choose to undergo scheduled and/or urgent surgery under general anesthesia and/or sedation at our hospital over a two-year period (2024-2025).

Diagnostic Test: Gastric Ultrasound

Interventions

Gastric Ultrasound DIAGNOSTIC_TEST

Gastric Ultrasound

Treatment with GLP-1 agonists

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The reference population will consist of patients undergoing scheduled surgery with a conventional preoperative fasting period (at least 6 hours).

You may qualify if:

• Adults patients ,ASA I-III, taking GLP-1 analog medications, undergoing scheduled surgery.

You may not qualify if:

• \- History of esophagogastric pathology or previous abdominal surgery.
• \- Hiatal hernia/gastroesophageal reflux disease.
• \- Autonomic nervous system disorders.
• \- Neurological or neuromuscular diseases.
• \- Use of medications/drugs that affect autonomic regulation and delay gastric emptying (opioids) or potentiate it (prokinetics).
• \- Pregnancy.
• \- Presence of arrhythmias.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (2)

Clinica Universidad Navarra

Madrid, Madrid, 28027, Spain

RECRUITING

CAUSA Salamanca

Salamanca, Spain

RECRUITING

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Carlos Puga Carrasco, MD

CONTACT

0034913531920; cpuga@unav.es

Miguel Angel Fernandez-Vaquero, MD,PhD

CONTACT

0034913531920; mferva7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 30, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

ES (2)