Pulmonary Aspiration
Conditions
Keywords
Glucagon Like Peptide-1 Receptor (GLP-1 RA), full stomach
Brief 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 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.
Interventions
OTHERGLP-1 RA users with prolonged fasting instructions
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.
OTHERGLP-1 RA users with standard NPO instructions
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists * Undergoing upper endoscopy only - no colonoscopy due to prep
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. * Patients on erythromycin, metoclopramide, domperidone, opioids. * Gastroparesis previous
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that show prevalence of increased RGC determined using preoperative GUS | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that show thirst as assessed by the VAS | prior to procedure ( within 2 hours before procedure) | This is measured in a linear scale from 1-10, higher number showing worse outcome |
| Number of participants that show hunger as assessed by the VAS | prior to procedure ( within 2 hours before procedure) | This is measured in a linear scale from 1-10, higher number showing worse outcome |
| Number of participants that show anxiety as assessed by the VAS | prior to procedure ( within 2 hours before procedure) | This is measured in a linear scale from 1-10, higher number showing worse outcome |
Countries
United States
Contacts
CONTACTSudipta Sen, MD, FASA
CONTACTPaul Potnuru
PRINCIPAL_INVESTIGATORSudipta Sen, MD, FASA
The University of Texas Health Science Center, Houston
Outcome results
None listed