Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06666049

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
39 (estimated)
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers

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.

Detailed description

2\. 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. 3\. 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 4\. 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. 5\. 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. 6\. Results Study data will be analyzed by the investigators. Results will be disseminated through scientific publications and presentations.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTGastric UltrasoundGastric Ultrasound

Timeline

Start date
2024-10-21
Primary completion
2026-11-01
Completion
2026-12-01
First posted
2024-10-30
Last updated
2026-04-14

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT06666049. Inclusion in this directory is not an endorsement.