Pulmonary Aspiration During Anaesthetic InductionGLP-1NCT06659159
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying
An observational study of Pulmonary Aspiration During Anaesthetic Induction, run by Sascha Battig.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Aspiration During Anaesthetic Induction
- What is being tested?
- Gastric ultrasound
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GLP-1 Therapy
Who may be able to join
- Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
- Signed informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med. contact
About this study
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.
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 surgery, but this recommendation has faced criticism for being too broad. More data on this issue is needed, particularly concerning the effect of tachyphylaxis (reduced drug response over time) on gastric emptying.
The study proposes using gastric ultrasound as a non-invasive tool to evaluate residual gastric content and categorize patients by their aspiration risk. The study will assess the stomach's content and gastric emptying time in patients both before and after starting GLP-1 therapy, comparing results under standard fasting conditions.
The project is a national, single-center, prospective observational study targeting 50 patients, examining factors like patient demographics, GLP-1 therapy details, and gastrointestinal side effects. Data collection will occur through baseline and follow-up sonographic exams before and after therapy initiation. The study aims to improve perioperative management strategies by clarifying the risks associated with GLP-1 therapy
Read the 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. Recent reports suggest that patients taking GLP-1 agonists may be at increased risk for aspiration, even when adhering to standard perioperative fasting guidelines (6 hours for solids, 2 hours for liquids).
The American Society of Anesthesiologists (ASA) has issued a warning about the potential risk of aspiration in patients on GLP-1 agonist therapy, recommending pausing the medication before surgery. However, this recommendation has been criticized for being too broad, given the lack of comprehensive data on the exact impact of GLP-1 agonists on gastric emptying and aspiration risk. Since many patients treated with GLP-1 agonists are already at higher risk of aspiration due to comorbidities like obesity and diabetes, understanding how this therapy further affects gastric function is crucial. There are also indications of a "tachyphylaxis" effect, where patients develop tolerance to the drug's impact over time, but its effect on gastric emptying and perioperative aspiration risk is not well understood.
Study Rationale and Objectives
The primary aim of this study is to assess whether patients undergoing GLP-1 agonist therapy have a higher likelihood of a full stomach after the recommended fasting intervals. Additionally, the study aims to evaluate the time taken for gastric emptying in these patients, focusing on the clearance of 500 ml of water.
Study Design
The project is a national, single-center, prospective observational study that will include approximately 50 patients who are starting GLP-1 agonist therapy. Patients will serve as their own control group by undergoing gastric ultrasound before beginning treatment and then again 6-8 weeks after therapy initiation. If therapy is continued, a follow-up ultrasound will occur around 5 months later.
The ultrasound examinations will measure both the gastric content (solid, liquid, or empty) and the cross-sectional area (CSA) of the gastric antrum to estimate gastric volume. These measurements will provide insight into whether patients on GLP-1 agonists have prolonged gastric emptying, contributing to the risk of aspiration during surgery.
Study Population and Procedures
The study population will consist of patients prescribed GLP-1 agonists for obesity, diabetes, or lifestyle reasons. Inclusion criteria include adults beginning a new GLP-1 therapy regimen, while exclusion criteria rule out patients with known gastrointestinal disorders, previous GI surgery, pregnancy, and those at high risk for hypoglycemia due to other medications like sulfonylureas or insulin.
Recruitment will occur through collaboration with the Adipositas und StoffwechselZentrum Hirslanden Zurich, where GLP-1 agonists are regularly prescribed. Patients will be contacted by phone to provide initial study information, and written informed consent will be obtained before the baseline examination. A demographic and medical history will also be collected at the initial visit.
- Being tested
- Gastric ultrasound
- Keywords
- Pulmonary aspiration, Gastric ultrasound, GLP-1, Gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic test
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 water, the stomach emptying will simultaneously be tracked with gastric ultrasound).
In accordance with the first endocrinological control examination (6-8 weeks after therapy initiation) the same gastric ultrasound examination is performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (8)
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: At the baseline examination at the first endocrinologic appointment
Side effects GLP-1
Collection of all side-effects of the GLP-1 therapy
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Aspiration During Anaesthetic InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sascha Battig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sascha Battig, Klinik Hirslanden, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659159
- Sponsor's protocol ID
- Effects of beginning a GLP1
- Other IDs
- Hirslanden Klinik
- Acronym
- GLP-1
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06659159
- Acronym / sponsor ID
- GLP-1 / Effects of beginning a GLP1
- Keywords
- Pulmonary aspiration, Gastric ultrasound, GLP-1, Gastroparesis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sascha BattigUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 surgery, but this recommendation has faced criticism for being too broad. More data on this issue is needed, particularly concerning the effect of tachyphylaxis (reduced drug response over time) on gastric emptying.
The study proposes using gastric ultrasound as a non-invasive tool to evaluate residual gastric content and categorize patients by their aspiration risk. The study will assess the stomach's content and gastric emptying time in patients both before and after starting GLP-1 therapy, comparing results under standard fasting conditions.
The project is a national, single-center, prospective observational study targeting 50 patients, examining factors like patient demographics, GLP-1 therapy details, and gastrointestinal side effects. Data collection will occur through baseline and follow-up sonographic exams before and after therapy initiation. The study aims to improve perioperative management strategies by clarifying the risks associated with GLP-1 therapy
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. Recent reports suggest that patients taking GLP-1 agonists may be at increased risk for aspiration, even when adhering to standard perioperative fasting guidelines (6 hours for solids, 2 hours for liquids).
The American Society of Anesthesiologists (ASA) has issued a warning about the potential risk of aspiration in patients on GLP-1 agonist therapy, recommending pausing the medication before surgery. However, this recommendation has been criticized for being too broad, given the lack of comprehensive data on the exact impact of GLP-1 agonists on gastric emptying and aspiration risk. Since many patients treated with GLP-1 agonists are already at higher risk of aspiration due to comorbidities like obesity and diabetes, understanding how this therapy further affects gastric function is crucial. There are also indications of a "tachyphylaxis" effect, where patients develop tolerance to the drug's impact over time, but its effect on gastric emptying and perioperative aspiration risk is not well understood.
Study Rationale and Objectives
The primary aim of this study is to assess whether patients undergoing GLP-1 agonist therapy have a higher likelihood of a full stomach after the recommended fasting intervals. Additionally, the study aims to evaluate the time taken for gastric emptying in these patients, focusing on the clearance of 500 ml of water.
Study Design
The project is a national, single-center, prospective observational study that will include approximately 50 patients who are starting GLP-1 agonist therapy. Patients will serve as their own control group by undergoing gastric ultrasound before beginning treatment and then again 6-8 weeks after therapy initiation. If therapy is continued, a follow-up ultrasound will occur around 5 months later.
The ultrasound examinations will measure both the gastric content (solid, liquid, or empty) and the cross-sectional area (CSA) of the gastric antrum to estimate gastric volume. These measurements will provide insight into whether patients on GLP-1 agonists have prolonged gastric emptying, contributing to the risk of aspiration during surgery.
Study Population and Procedures
The study population will consist of patients prescribed GLP-1 agonists for obesity, diabetes, or lifestyle reasons. Inclusion criteria include adults beginning a new GLP-1 therapy regimen, while exclusion criteria rule out patients with known gastrointestinal disorders, previous GI surgery, pregnancy, and those at high risk for hypoglycemia due to other medications like sulfonylureas or insulin.
Recruitment will occur through collaboration with the Adipositas und StoffwechselZentrum Hirslanden Zurich, where GLP-1 agonists are regularly prescribed. Patients will be contacted by phone to provide initial study information, and written informed consent will be obtained before the baseline examination. A demographic and medical history will also be collected at the initial visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1, New Therapy | – | Diagnostic Test: Gastric ultrasoundIndication, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GLP-1 Therapy
Key inclusion criteria (2 listed)
- Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasoundThe 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 water, the stomach emptying will simultaneously be tracked with gastric ultrasound). In accordance with the first endocrinological control examination (6-8 weeks after therapy initiation) the same gastric ultrasound examination is performed. | Diagnostic test | GLP-1, New Therapy |
Primary outcome
Gastric content
Time frame: 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
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
8 secondary outcomes
Gastric emptying time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the baseline examination at the first endocrinologic appointment
Side effects GLP-1
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med. contact
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Aspiration During Anaesthetic Induction, run by Sascha Battig.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med. (+41 44 387 38 80, Michael.Ganter@hirslanden.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric content (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.