Pulmonary AspirationNCT05889637
Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists
An observational study of Pulmonary Aspiration, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Aspiration
- What is being tested?
- Gastric ultrasound
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 12 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: subjects presenting for elective surgery who are on Glucagon-Like peptide-1 agonist subcutaneous injection, once weekly will be included
Who may be able to join
- Patients taking GLP-1receptor agonists (N=62)
- Patients not taking GLP-1 receptor agonists (N=62)
Who cannot join
- Previous gastric resection or bypass
- Gastric band in situ
- Previous fundoplication
- Large hiatal hernia
- Pregnant patients
- Recent trauma
- Inability to turn to the right lateral decubitus position
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1(GLP-1) Receptor Agonists
The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1 receptor agonists.
- Conditions
- Pulmonary Aspiration
- Being tested
- Gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic test
Patient will be scanned first in the supine position and then in the right lateral decubitus position. The ultrasound probe will be placed in a sagittal plane in the epigastric region at the left subcostal margin and then will be moved past the midline in a fan like manner to the right subcostal region. Qualitative and quantitative assessments will be done.
| Study group | Role | What they receive |
|---|---|---|
| Group G: Patients taking GLP-1receptor agonists | Not described Receives: Diagnostic Test: Gastric ultrasound | |
| Group C: Patients not taking GLP-1 receptor agonists (control group) | Not described Receives: Diagnostic Test: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that are at risk for aspiration
Risk for aspiration is indicated by the presence of solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position
Measured: end of ultrasound
Number of subjects that are at low risk for aspiration
Low risk for aspiration is indicated by a collapsed gastric antrum or clear fluids <1.5ml/kg in the gastric antrum in the right lateral decubitus position.
Measured: end of ultrasound
Secondary outcomes (10)
Age
Measured: end of ultrasound
Number of participants that are male as indicated in the medical records
Measured: end of ultrasound
Number of participants that are female as indicated in the medical records
Measured: end of ultrasound
Body mass Index (BMI)
Body Mass Index (BMI) is calculated as the body mass in kilograms (kg) divided by the square of the body height in meters, and is expressed in units of kg/m2.
Measured: end of ultrasound
Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system
The classification ranges from American Society of Anesthesiologists (ASA)1 (normal healthy person ) to ASA IV (A patient with severe systemic disease that is a constant threat to life)
Measured: end of ultrasound
Number of participants with diabetes
Measured: end of ultrasound
Number of participants with reported nothing by mouth (NPO) status
Measured: end of ultrasound
Pain severity as assessed by the numeric scale
This is a 11 point scale with scores ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: end of ultrasound
Number of participants with Gastroesophageal reflux disease (GERD)
Measured: end of ultrasound
Number of participants that have use opioids preoperatively
Measured: end of ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start6 Jun 2023
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AspirationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- 132 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudipta Sen, The University of Texas Health Science Center, Houston
- Investigators
- Sudipta Sen, MD,FASA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889637
- Sponsor's protocol ID
- HSC-MS-23-0300
- Status last verified
- Aug 2023
- First submitted
- 8 May 2023
- Last updated
- 2 Aug 2023
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1(GLP-1) Receptor Agonists
- ClinicalTrials.gov ID
- NCT05889637
- Acronym / sponsor ID
- HSC-MS-23-0300
- Conditions
- Pulmonary Aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 5 Jun 2023 (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.
The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1 receptor agonists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group G: Patients taking GLP-1receptor agonists | – | Diagnostic Test: Gastric ultrasound |
| Group C: Patients not taking GLP-1 receptor agonists (control group) | – | Diagnostic Test: Gastric ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects presenting for elective surgery who are on Glucagon-Like peptide-1 agonist subcutaneous injection, once weekly will be included
Key inclusion criteria (2 listed)
- Patients taking GLP-1receptor agonists (N=62)
- Patients not taking GLP-1 receptor agonists (N=62)
Key exclusion criteria (7 listed)
- Previous gastric resection or bypass
- Gastric band in situ
- Previous fundoplication
- Large hiatal hernia
- Pregnant patients
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 ultrasoundPatient will be scanned first in the supine position and then in the right lateral decubitus position. The ultrasound probe will be placed in a sagittal plane in the epigastric region at the left subcostal margin and then will be moved past the midline in a fan like manner to the right subcostal region. Qualitative and quantitative assessments will be done. | Diagnostic test | Group C: Patients not taking GLP-1 receptor agonists (control group), Group G: Patients taking GLP-1receptor agonists |
Primary outcome
Number of subjects that are at risk for aspiration
Time frame: end of ultrasound
Risk for aspiration is indicated by the presence of solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position
Number of subjects that are at low risk for aspiration
Time frame: end of ultrasound
Low risk for aspiration is indicated by a collapsed gastric antrum or clear fluids <1.5ml/kg in the gastric antrum in the right lateral decubitus position.
10 secondary outcomes
Age
Time frame: end of ultrasound
Number of participants that are male as indicated in the medical records
Time frame: end of ultrasound
Number of participants that are female as indicated in the medical records
Time frame: end of ultrasound
Body mass Index (BMI)
Time frame: end of ultrasound
Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system
Time frame: end of ultrasound
Number of participants with diabetes
Time frame: end of ultrasound
Number of participants with reported nothing by mouth (NPO) status
Time frame: end of ultrasound
Pain severity as assessed by the numeric scale
Time frame: end of ultrasound
Number of participants with Gastroesophageal reflux disease (GERD)
Time frame: end of ultrasound
Number of participants that have use opioids preoperatively
Time frame: end of ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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. This study is not recruiting at the moment.
Sudipta Sen, MD,FASA principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Aspiration, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 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: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects that are at risk for aspiration (time frame: end of ultrasound). The study lists 2 primary outcomes in all. 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 2 Aug 2023.