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NCT Number: NCT06666049

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Universidad Navarra, Madrid, Spain

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About this study

  • Hypothesis

Gastric ultrasonography performed by trained anesthesiologists is a useful tool for assessing gastric content and may support clinical decision-making in airway management in patients treated with GLP-1 receptor agonists.

  • Methodology

This is a prospective, observational cohort study conducted at participating centers.

The study population consists of adult patients undergoing scheduled surgery under general anesthesia following a standard preoperative fasting period.

Inclusion criteria

  • Patients receiving treatment with GLP-1 receptor agonists
  • Age ≥18 years
  • Scheduled surgery after a fasting period between 6 and 8 hours
  • ASA physical status I-III
  • Ability to provide informed consent

Exclusion criteria

  • History of esophagogastric pathology or prior upper abdominal surgery
  • Hiatal hernia or gastroesophageal reflux disease
  • Autonomic nervous system disorders
  • Neurological or neuromuscular diseases
  • Use of medications affecting gastric emptying (e.g., opioids or prokinetics)
  • Pregnancy
  • Presence of clinically significant arrhythmias
  • Description of the Intervention

Immediately prior to anesthesia induction, gastric ultrasonography will be performed by trained investigators at participating centers, with the patient in both supine and right lateral decubitus positions.

Qualitative, semi-quantitative, and quantitative assessments of gastric content and volume will be performed according to the methodology described by Perlas et al. Data will be recorded in a standardized study database.

Anesthetic and surgical management will proceed according to routine clinical practice.

  • Ethical, Legal, and Economic Considerations

Written informed consent will be obtained from all participants prior to study inclusion.

This is an observational study with no modification of standard clinical care. No additional risks beyond routine clinical practice are anticipated.

Gastric ultrasonography will be performed using equipment available at participating centers, and no additional costs are expected.

  • Results

Study data will be analyzed by the investigators. Results will be disseminated through scientific publications and presentations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • - 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.

Treatment and study plan

Gastric ultrasound

Diagnostic Test

Gastric Ultrasound

Primary outcomes

  1. Gastric Ultrasound

    Time frame: Immediately prior to induction of anesthesia

    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.

Secondary outcomes

  1. weight in kilograms

    Time frame: Immediately prior to induction of anesthesia

    Weight in kilograms

  2. Height in centimeters

    Time frame: Immediately prior to induction of anesthesia

    Height in centimeters

  3. BMI in kg/m^2

    Time frame: Immediately prior to induction of anesthesia

    Weight and height will be combined to report BMI in kg/m^2

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Puga Carrasco, MD

CONTACT

[email protected]

0034913531920 ext. 7633

Miguel Angel Fernandez-Vaquero, MD,PhD

CONTACT

[email protected]

0034913531920 ext. 7633

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Acronym: POCUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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