Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06659159 (GLP-1) for Pulmonary Aspiration During Anaesthetic Induction is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying (GLP-1) 50 Non-Invasive Observational
Clinical Trial NCT06659159 (GLP-1) is an observational study for Pulmonary Aspiration During Anaesthetic Induction and is currently not yet recruiting. Enrollment is planned to begin on 1 November 2024 and continue until the study accrues 50 participants. Led by Sascha Battig, this study is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 26 October 2024.
Brief Summary
This project explores the elevated risk of pulmonary aspiration during anesthesia in patients undergoing GLP-1 agonist therapy, which prolongs gastric emptying. Despite standard fasting guidelines (6 hours for solids, 2 hours for liquids), some patients still experience aspiration, indicating that GLP-1 therapy may heighten risk. The American Society of Anesthesiologists has advised pausing GLP-1 therapy before surge...Show More
Detailed Description
This project investigates the risk of pulmonary aspiration during anesthesia in patients undergoing treatment with GLP-1 agonists, a class of medications that prolong gastric emptying and are commonly used for obesity and diabetes management. Pulmonary aspiration remains a significant cause of morbidity and mortality in anesthesia-related complications, and patients with delayed gastric emptying are at higher risk. R...Show More
Official Title
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying: a Prospective Ultrasound Approach with Focus on Perioperative Aspiration Risk.
Conditions
Pulmonary Aspiration During Anaesthetic InductionOther Study IDs
- GLP-1
- Effects of beginning a GLP1
- Hirslanden Klinik (Other Grant/Funding Number) (Hirslanden Klinik, Zurich)
NCT ID Number
Start Date (Actual)
2024-11-01
Last Update Posted
2024-10-26
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
50
Study Type
Observational
Status
Not yet recruiting
Keywords
Pulmonary aspiration
Gastric ultrasound
GLP-1
Gastroparesis
Gastric ultrasound
GLP-1
Gastroparesis
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
GLP-1, New Therapy Indication, prescription and dosage is determined independently of the study by the endocrinologist/obesity specialist, who is also part of the study team. Since the first gastric ultrasound will take place directly before the initiation of the GLP-1 Agonist therapy, the patients will serve as their own control group/baseline. | Gastric ultrasound The sequence in which the study is conducted will be as follows, the first examination (baseline examination) will take place immediately before the appointment and prescription of GLP-1 Analoga (before the first injection). During the examination the gastric content (quality/quantity) will be determined, secondly, a baseline for gastric emptying time after oral intake of 500ml of water is collected (patient drinks w...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Gastric content | Sonographic assessment of the gastric content (quality and quantity) after a standardised meal and regular perioperative fasting interval (at least 6 hours for solids and 2 hours for liquids) before initiation and once 6-8 weeks after GLP-1 therapy initiation | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Gastric emptying time | Sonographic measurement of gastric emptying time for 500ml of water before and during GLP-1 therapy. Gastric emptying time is measured with a continuous ultrasound examination. The variable of interest is once again the CSA of the gastric antrum and the time until the baseline from before water consumption is reached once again. | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Number of empty stomachs | Absolute number of empty stomachs after adhering to standardised perioperative fasting intervals (6 hours for solids and 2 hours for liquids) before and once (if therapy is continued: twice) during GLP-1 Agonist therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
BMI | Demographic data of the patient: BMI | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Gallbladder stones | Presence of gallbladder stones (cholecystolithiasis) | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Co-morbidities | Demographic data of the patients: Comorbidities | At the baseline examination at the first endocrinologic appointment |
Side effects GLP-1 | Collection of all side-effects of the GLP-1 therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Discontinuation GLP-1 | Number and reason for discontiuation of GLP-1 therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Co-medication | For gastric emptying relevant co-medications | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
- Signed informed consent
- Known pregnancy, known lactation
- Underage (< 18 years)
- Absence of informed consent (missing or inability to provide)
- Anomalies of the gastrointestinal tract
- Known illnesses of the gastrointestinal tract
- Previous surgery of the gastrointestinal tract
- Elevated risk for hypoglycaemia (Sulfonylurea or Insulin)
- No investigator with completed structural education in gastric sonography is available
- Lack of intention to respect the fasting intervals and predefined standardised meals for the sonographic examination
Sascha BattigStudy Responsible Party
Sascha Battig, Sponsor-Investigator, Prof. Dr. med. Michael Ganter, Klinik Hirslanden, Zurich
Study Central Contact
Contact: Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med., +41 44 387 38 80, [email protected]
No location data.