Pulmonary AspirationNCT06654219
Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) Agonist Prior to Anesthesia
A study testing GLP-1 RA users with prolonged fasting instructions and GLP-1 RA users with standard NPO instructions in people with 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 if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and… 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?
- GLP-1 RA users with prolonged fasting instructions and GLP-1 RA users with standard NPO instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
- Undergoing upper endoscopy only - no colonoscopy due to prep
Who cannot join
- Previous gastric resection or bypass
- Gastric band in situ
- Previous fundoplication
- Large hiatal hernia
- Pregnant patients
- Recent trauma
Show all 9Show fewer
- Inability to turn to the right lateral decubitus position.
- Patients on erythromycin, metoclopramide, domperidone, opioids.
- Gastroparesis previous
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sudipta Sen, MD, FASA, (713) 500-6202, Sudipta.Sen@uth.tmc.edu
Paul Potnuru, (713) 500-6271, Paul.Potnuru@uth.tmc.edu
About this study
Official title: Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor Agonist Prior to Anesthesia
The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.
- Conditions
- Pulmonary Aspiration
- Being tested
- GLP-1 RA users with prolonged fasting instructions, GLP-1 RA users with standard NPO instructions
- Keywords
- Glucagon Like Peptide-1 Receptor (GLP-1 RA), full stomach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 RA users with prolonged fasting instructionsOther
NPO for solids: 24 hours prior to procedure, clear liquid diet (CLD) for 24 hours with last intake of clears no less than 2 hours prior to a procedure.GLP-1 RA will not be held prior to surgery and usual dosing schedule will be followed prior to procedure.
GLP-1 RA users with standard NPO instructionsOther
NPO after midnight prior to procedure; Minimum solid fasting duration of 8 hours for solids and 2 hours for liquids. Last dose of GLP-1 RA no less than 7 days prior to procedure.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 RA users with prolonged fasting instructions | Experimental | Not described Receives: Other: GLP-1 RA users with prolonged fasting instructions |
| GLP-1 RA users with standard NPO instructions | Active comparator | Not described Receives: Other: GLP-1 RA users with standard NPO instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that show prevalence of increased RGC determined using preoperative GUS
Participants with increased RGC will have solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position
Measured: prior to procedure ( within 2 hours before procedure)
Secondary outcomes (3)
Number of participants that show thirst as assessed by the VAS
This is measured in a linear scale from 1-10, higher number showing worse outcome
Measured: prior to procedure ( within 2 hours before procedure)
Number of participants that show hunger as assessed by the VAS
This is measured in a linear scale from 1-10, higher number showing worse outcome
Measured: prior to procedure ( within 2 hours before procedure)
Number of participants that show anxiety as assessed by the VAS
This is measured in a linear scale from 1-10, higher number showing worse outcome
Measured: prior to procedure ( within 2 hours before procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Oct 2025
- Primary completion31 Dec 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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 136 participants (estimated)
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
- NCT06654219
- Sponsor's protocol ID
- HSC-MS-24-0940
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2024
- Last updated
- 4 Aug 2026
- Results posted
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor Agonist Prior to Anesthesia
- ClinicalTrials.gov ID
- NCT06654219
- Acronym / sponsor ID
- HSC-MS-24-0940
- Conditions
- Pulmonary Aspiration
- Keywords
- Glucagon Like Peptide-1 Receptor (GLP-1 RA), full stomach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 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.
The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RA users with prolonged fasting instructions | Experimental | Other: GLP-1 RA users with prolonged fasting instructions |
| GLP-1 RA users with standard NPO instructions | Active comparator | Other: GLP-1 RA users with standard NPO instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
- Undergoing upper endoscopy only - no colonoscopy due to prep
Key exclusion criteria (9 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 |
|---|---|---|
| GLP-1 RA users with prolonged fasting instructionsNPO for solids: 24 hours prior to procedure, clear liquid diet (CLD) for 24 hours with last intake of clears no less than 2 hours prior to a procedure.GLP-1 RA will not be held prior to surgery and usual dosing schedule will be followed prior to procedure. | Other | GLP-1 RA users with prolonged fasting instructions |
| GLP-1 RA users with standard NPO instructionsNPO after midnight prior to procedure; Minimum solid fasting duration of 8 hours for solids and 2 hours for liquids. Last dose of GLP-1 RA no less than 7 days prior to procedure. | Other | GLP-1 RA users with standard NPO instructions |
Primary outcome
Number of participants that show prevalence of increased RGC determined using preoperative GUS
Time frame: prior to procedure ( within 2 hours before procedure)
Participants with increased RGC will have solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position
3 secondary outcomes
Number of participants that show thirst as assessed by the VAS
Time frame: prior to procedure ( within 2 hours before procedure)
Number of participants that show hunger as assessed by the VAS
Time frame: prior to procedure ( within 2 hours before procedure)
Number of participants that show anxiety as assessed by the VAS
Time frame: prior to procedure ( within 2 hours before procedure)
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 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Aspiration
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
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.
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?
A study testing GLP-1 RA users with prolonged fasting instructions and GLP-1 RA users with standard NPO instructions in people with 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 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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?
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 Sudipta Sen, MD, FASA ((713) 500-6202, Sudipta.Sen@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that show prevalence of increased RGC determined using preoperative GUS (time frame: prior to procedure ( within 2 hours before procedure)). 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 4 Aug 2026.