ClinicalTrials.gg
CompletedNCT05889637Updated Aug 2, 2023

Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists

An observational study in Pulmonary Aspiration, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
132
Ages
18 Years and older
Sex
All
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Study 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 receptor agonists.

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Conditions studied

  • Pulmonary Aspiration
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In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

subjects presenting for elective surgery who are on Glucagon-Like peptide-1 agonist subcutaneous injection, once weekly will be included

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients taking GLP-1receptor agonists (N=62)
  • Patients not taking GLP-1 receptor agonists (N=62)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
132 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testGastric ultrasound

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: end of ultrasound

  2. 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.

    Time frame: end of ultrasound

Secondary outcomes

  1. Age

    Time frame: end of ultrasound

  2. Number of participants that are male as indicated in the medical records

    Time frame: end of ultrasound

  3. Number of participants that are female as indicated in the medical records

    Time frame: end of ultrasound

  4. 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.

    Time frame: end of ultrasound

  5. 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)

    Time frame: end of ultrasound

  6. Number of participants with diabetes

    Time frame: end of ultrasound

  7. Number of participants with reported nothing by mouth (NPO) status

    Time frame: end of ultrasound

  8. 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)

    Time frame: end of ultrasound

  9. Number of participants with Gastroesophageal reflux disease (GERD)

    Time frame: end of ultrasound

  10. Number of participants that have use opioids preoperatively

    Time frame: end of ultrasound

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Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jul 2023, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2023
First posted
Jun 5, 2023
StartActual
Jun 6, 2023
Primary completionActual
Jul 12, 2023
CompletionActual
Jul 12, 2023
Last update
Aug 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05889637
Responsible party
Sudipta Sen (Assisstant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jun 5, 2023
Start date
Jun 6, 2023
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023
Last update
Aug 2, 2023

Study contacts

Sudipta Sen, MD,FASA
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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