Aspiration PneumoniaPOCUSNCT06666049
Gastric POCUS for Airway Management in Patients Using Glucagon-like Peptide-1 Receptor Agonist (Multicentric)
An observational study of Aspiration Pneumonia, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- Gastric Ultrasound
- How many people
- 39 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Oct 2024to 1 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 to 90 years
- All sexes
- Adult, Older adult
Study population: The reference population will consist of patients undergoing scheduled surgery with a conventional preoperative fasting period (at least 6 hours).
Who may be able to join
- Adults patients ,ASA I-III, taking GLP-1 analog medications, undergoing scheduled surgery.
Who cannot join
- - 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clinica Universidad Navarra
Madrid, Madrid, 28027
Miguel Angel Fernandez-Vaquero, MD,PhD, 0034913531920 ext. 7633, mfvaquero@unav.es
- Recruiting
CAUSA Salamanca
Salamanca
Jose Alfonso Sastre
Jose Alfonso Sastre
About this study
- 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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Aspiration Pneumonia
- Being tested
- Gastric Ultrasound
- Keywords
- Bronchopulmonary complications, Ultrasound
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric UltrasoundDiagnostic test
Gastric Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Gastric Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately prior to induction of anesthesia
Secondary outcomes (3)
weight in kilograms
Weight in kilograms
Measured: Immediately prior to induction of anesthesia
Height in centimeters
Height in centimeters
Measured: Immediately prior to induction of anesthesia
BMI in kg/m^2
Weight and height will be combined to report BMI in kg/m^2
Measured: Immediately prior to induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start21 Oct 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666049
- Sponsor's protocol ID
- POCUS
- Acronym
- POCUS
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric POCUS for Airway Management in Patients Using Glucagon-like Peptide-1 Receptor Agonist (Multicentric)
- ClinicalTrials.gov ID
- NCT06666049
- Acronym / sponsor ID
- POCUS / POCUS
- Conditions
- Aspiration Pneumonia
- Keywords
- Bronchopulmonary complications, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 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.
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with GLP-1 agonists | – | Diagnostic Test: Gastric UltrasoundPatients 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The reference population will consist of patients undergoing scheduled surgery with a conventional preoperative fasting period (at least 6 hours).
Key inclusion criteria (1 listed)
- Adults patients ,ASA I-III, taking GLP-1 analog medications, undergoing scheduled surgery.
Key exclusion criteria (7 listed)
- - 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).
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 UltrasoundGastric Ultrasound | Diagnostic test | Treatment with GLP-1 agonists |
Primary outcome
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.
3 secondary outcomes
weight in kilograms
Time frame: Immediately prior to induction of anesthesia
Height in centimeters
Time frame: Immediately prior to induction of anesthesia
BMI in kg/m^2
Time frame: Immediately prior to induction of anesthesia
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 5 May 2026.
Related trials for Aspiration Pneumonia
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
RecruitingPhase 4
Gastrointestinal Dysmotility on Aspiration Risk
Esophageal Motility Disorders, Gastric Motor Dysfunction
Not yet recruitingObservational study
Surveillance of Neonatal Endotracheal Tube Colonisation
Ventilation, Mechanical, Ventilation-Associated Pneumonia
Not yet recruiting
Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
Acute Ischemic Stroke, Stroke-Associated Pneumonia (SAP)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration Pneumonia, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Carlos Puga Carrasco, MD (0034913531920 ext. 7633, cpuga@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Ultrasound (time frame: Immediately prior to induction of anesthesia). 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 5 May 2026.