Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154486
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2023-09-14
Brief Title:
Evaluation of Gastric Content of Volunteers Fasting and Using Semaglutide an Observational and Cross-sectional Study
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Evaluation of Gastric Content of Volunteers Fasting and Using Semaglutide an Observational and Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medicines with peptide-1 receptor agonist action similar to glucagon GLP-1 are a modern therapeutic option for obesity and diabetes mellitus Semaglutide is a representative of this class medication whose mechanism of action can result in the slowing of gastric emptying and reduced gastric motility a scenario that can increase the risk of pulmonary aspiration in individuals undergoing anesthesia and despite adequate fasting Given the severity of the occurrence of bronchoaspiration the action biological analysis of GLP-1 analogues on gastric function and incremental use of these medications through gastric ultrasound we will aim to evaluate the gastric contents of volunteers who do not have risk factors for bronchoaspiration who will not undergo anesthesia but are with the fasting recommended for this purpose and are using semaglutide an analogue of GLP-1 Our hypothesis is that the majority of individuals using these medications have a full stomach even during fasting times recommended in the literature In view of this for this population we must adapt safety criteria during the anesthetic procedure
Detailed Description:
INTRODUCTION
Obesity and type 2 diabetes mellitus constitute a global public health problem Medications with glucagon-like peptide-1GLP-1 receptor agonist action are a modern therapeutic option for both diseases Liraglutide semaglutide and dulaglutide are some representatives of this drug class whose mechanism of action results in slowing gastric emptying reduced gastric motility and increased gastric volume These effects are implicated in both weight loss and the occurrence of adverse events such as nausea vomiting acute gastroparesis and gastroesophageal reflux disease GERD The presence of gastric contents during the anesthetic procedure can lead to pulmonary aspiration and the development of chemical pneumonitis a potentially fatal complication To avoid this risk in healthy patients an 8-hour fast for solids and 2 hours for clear liquids However when there is a risk factor for slow gastric emptying despite adequate fasting the stomach may present residues and bedside ultrasound is an effective non-invasive and quickly to measure this content and stratify the risk of aspiration Due to the lack of studies demonstrating that the use of GLP-1 analogue can increase the risk of aspiration in individuals who are fasting adequately to receive anesthesia there is no formal recommendation for performing gastric ultrasound in the preoperative period nor for the suspension of these medications Some institutions empirically recommend suspension preoperatively
Given the severity of the occurrence of bronchoaspiration the biological action of GLP-1 analogues on gastric function and the incremental use of these medications it is necessary to better understand the gastric contents of individuals fasting and using a GLP-1 analogue GLP-1 Thus through ultrasound we will aim to evaluate the gastric contents of volunteers who do not have risk factors for bronchoaspiration who will not undergo anesthesia but are fasting recommended for this purpose and are using semaglutide a GLP-1 analogue
Our hypothesis is that the majority of individuals using these medications have a full stomach even with the fasting times recommended in the literature In view of this for this population we must adapt safety criteria during the anesthetic procedure
Objectives Primary objective The primary objective is to evaluate the prevalence of a full stomach through gastric ultrasound examination in volunteers who use semaglutide and are fasting for at least 8 hours for solids and 2 hours for clear liquids As a control group we will use volunteers who do not use semaglutide
Secondary objectives The secondary objectives consist of evaluating whether the demographic characteristics of the volunteers the time of medication use the time elapsed since the last dose of semaglutide received the dose and regimen of medication use the reason for using the medication the presence Symptoms such as nausea vomiting loss of appetite and sensation of gastric fullness can influence gastric emptying when these individuals are evaluated by ultrasound
Study Design Observational cross-sectional non-interventional study
study population
30 volunteers will be included in the study of which 15 must be currently using semaglutide and 15 must not be using the medication The gastric ultrasonography will be performed at Hospital Israelita Albert Einstein in the radiologist medicine sector by an anesthesiologist with experience in gastric ultrasonography The images will be registered in the picture archiving and communication system and reviewed by a radiologist
Sample size calculation Based on the literature individuals in the control group presented an area of residual liquid in the stomach ranging from 3cm² to 7cm² with a median area of 51cm² which respectively provide 324ml 908ml and 631ml of liquid volume residual after 8 hours of fasting assuming an average increase of at least 20ml of fluid in patients using semaglutide with 95 confidence and 80 power the sample required to carry out the study is 14 patients in each group To compensate for any losses we will increase the sample by 10 leaving 15 volunteers in each group
METHODS Study outcomes Primary outcome Compare the prevalence of a full stomach after fasting for at least 8 hours for solids and 2 hours for clear liquids through gastric ultrasound in volunteers using semaglutide with those who do not use the medication The outcome will be binary a full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 15mlkg It will be considered an empty stomach when no content or clear liquids are visible inferior to 15mlkg
Secondary outcomes
Assess the demographic characteristics of the volunteers
Describe the dose and regimen of medication use
Describe the reason for using the medication
Describe the presence of symptoms such as nausea vomiting and sensation of gastric fullness loss of appetite early satiety and abdominal pain
Describe the use of other medications
Risk factors for bronchoaspiration
Diabetes Mellitus with peripheral neuropathy or history of gastroparesis
Obesity Defined as body mass index BMI inferior to 30 kgm2
Active cancer
Gastroesophageal Reflux Disease
Use of opioids
History of surgery for obesity
Neurological disease
Chronic or acute kidney disease
Symptomatic hypothyroidism
Technical limitation for evaluation of gastric contents by ultrasonography
Previous gastric surgery such as partial gastrectomy or gastric bypass
Massive hiatus hernia
Proper fasting
Fasting will be considered adequate
general diet 8 hours
Clear liquids water juices without lumps 2 hours
Types of GLP-1 analogue
The following drugs will be considered
Semaglutide Ozempic Wegovy
Protocol for performing gastric ultrasonography
It consists of scanning the abdomen in the sagittal plane in the dorsal decubitus position at 45 degrees in the supine position and in the right lateral decubitus position with a curvilinear low-frequency ultrasound probe2 to 5 mHz and locating the gastric antrum through the identification of the main points of reference - left lobe of the liver and a main vessel aorta or inferior vena cava Gastric emptying will be assessed quantitatively and qualitatively through assessment of the composition of its contents and measurement of gastric volume respectively
The qualitative assessment will assess whether the stomach is empty with clear liquid or with solids The stomach is considered empty when the antrum presents itself with the anterior and posterior walls juxtaposed denoting a buffalo eye or target pattern a characteristic attributed by the identification of a hypoechoic thick external ring The antrum may appear empty in the supine position and fluid-filled in the right lateral decubitus position The volume of liquid must be measured in this position and if it is less than 15 mlkg average of 100ml in adults it is considered normal in fasting individuals and the risk of bronchoaspiration is considered low On the other hand the visualization of liquid both in the supine position and in the right lateral decubitus position is suggestive of a large gastric volume When the liquid measurement is greater than 15 mlkg the patient is at high risk for bronchoaspiration
Whenever clear liquids are visualized gastric volume is measured using the cross-sectional area of the gastric antrumAA using the external wall of the stomach which has a linear correlation with gastric volume This is performed in the right lateral decubitus position with two perpendicular diameters of the antrum from serosa to serosa the longitudinal or craniocaudal diameterCC and the anteroposterior diameter AP or using the ellipse formula developed by Bolondi where AACC AP π 4 With the value of π 314 After calculating the AA the total stomach volume predicted volume will be evaluated in each volunteer with a previously tested and validated mathematical model in which the stomach volumeml 27 146 x AA cm2 - 128 age in years
Collected variables Demographic data will be collected Ultrasound images will be registered in the radiology picture archiving and communication system Data will be collected in printed clinical records andor an electronic form specifically developed for the study using the REDCap Research Electronic Data Capture electronic form The authors will be responsible for monitoring the data
Demographic and baseline data
Verification of inclusion and exclusion criteria
Applicability and date of application of the informed consent form
Date of birth
Age in years
Gender
Ethnicity
Weight in kg
Height in cm
BMI in kgm2
Date of inclusion in the study
Data regarding the GLP-1 analogue
Semaglutide
Ozempic
Wegovy
Administration dosage
Time of medication use in months or weeks when time of use is less than 1 month
Previous use of semaglutide
Previous use of another medication from the GLP-1 analogue class
Reason for using the medication
Clinical symptoms of gastroparesis
Nausea
Vomiting
Abdominal pain
Sensation of gastric fullness
Early satiety
Loss of appetite
Use of other medications
Data regarding gastric ultrasound examination
Qualitative check
Full stomach - solid residue or clear liquid volume 15 mlkg
Empty stomach - no content or volume of clear liquid Volume 15 mlkg
STATISTICAL ANALYSIS Included patients will be divided into two groups according to the use or not of Semaglutide and the gastric residue found a full stomach or an empty stomach Differences between groups in relation to continuous numerical variables will be analyzed using the Student t test normal distribution or Mann-Whitney U test variables not normally distributed Proportions will be compared using the Chi-square test or Fishers Exact Test All significance probabilities p values presented will be two-tailed p-values will be considered statistically significant when less than 005 All analyzes will be performed using the software R 341 R Foundation for Statistical Computing Vienna Austria
SAFETY AND ETHICAL CONSIDERATIONS Risks and benefits Abdominal ultrasound is a non-invasive exam that does not emit radiation There is no evidence to support that the use of ultrasound can cause any harm to health The research participant may experience some discomfort related to fasting for 8 hours for solids and 2 hours for liquids
There are risks related to the loss of data confidentiality and the research team is responsible for taking all precautions to ensure data confidentiality
This study may benefit individuals who use this medication when undergoing anesthesia According to the results of this study suspension of this medication preoperatively or other safety measures may be recommended
Approval from ethical and regulatory authorities The study was approved by the Institutional review Board IRB and written consent from the patient will be requested
Data confidentiality The patient will be identified by the corresponding number on the electronic data collection form The data obtained must be kept confidential by the researchers and will be stored on the REDCAP Platform which allows restricted access to information according to security levels and individualized logins
Obesity and type 2 diabetes mellitus constitute a global public health problem Medications with glucagon-like peptide-1GLP-1 receptor agonist action are a modern therapeutic option for both diseases Liraglutide semaglutide and dulaglutide are some representatives of this drug class whose mechanism of action results in slowing gastric emptying reduced gastric motility and increased gastric volume These effects are implicated in both weight loss and the occurrence of adverse events such as nausea vomiting acute gastroparesis and gastroesophageal reflux disease GERD The presence of gastric contents during the anesthetic procedure can lead to pulmonary aspiration and the development of chemical pneumonitis a potentially fatal complication To avoid this risk in healthy patients an 8-hour fast for solids and 2 hours for clear liquids However when there is a risk factor for slow gastric emptying despite adequate fasting the stomach may present residues and bedside ultrasound is an effective non-invasive and quickly to measure this content and stratify the risk of aspiration Due to the lack of studies demonstrating that the use of GLP-1 analogue can increase the risk of aspiration in individuals who are fasting adequately to receive anesthesia there is no formal recommendation for performing gastric ultrasound in the preoperative period nor for the suspension of these medications Some institutions empirically recommend suspension preoperatively
Given the severity of the occurrence of bronchoaspiration the biological action of GLP-1 analogues on gastric function and the incremental use of these medications it is necessary to better understand the gastric contents of individuals fasting and using a GLP-1 analogue GLP-1 Thus through ultrasound we will aim to evaluate the gastric contents of volunteers who do not have risk factors for bronchoaspiration who will not undergo anesthesia but are fasting recommended for this purpose and are using semaglutide a GLP-1 analogue
Our hypothesis is that the majority of individuals using these medications have a full stomach even with the fasting times recommended in the literature In view of this for this population we must adapt safety criteria during the anesthetic procedure
Objectives Primary objective The primary objective is to evaluate the prevalence of a full stomach through gastric ultrasound examination in volunteers who use semaglutide and are fasting for at least 8 hours for solids and 2 hours for clear liquids As a control group we will use volunteers who do not use semaglutide
Secondary objectives The secondary objectives consist of evaluating whether the demographic characteristics of the volunteers the time of medication use the time elapsed since the last dose of semaglutide received the dose and regimen of medication use the reason for using the medication the presence Symptoms such as nausea vomiting loss of appetite and sensation of gastric fullness can influence gastric emptying when these individuals are evaluated by ultrasound
Study Design Observational cross-sectional non-interventional study
study population
30 volunteers will be included in the study of which 15 must be currently using semaglutide and 15 must not be using the medication The gastric ultrasonography will be performed at Hospital Israelita Albert Einstein in the radiologist medicine sector by an anesthesiologist with experience in gastric ultrasonography The images will be registered in the picture archiving and communication system and reviewed by a radiologist
Sample size calculation Based on the literature individuals in the control group presented an area of residual liquid in the stomach ranging from 3cm² to 7cm² with a median area of 51cm² which respectively provide 324ml 908ml and 631ml of liquid volume residual after 8 hours of fasting assuming an average increase of at least 20ml of fluid in patients using semaglutide with 95 confidence and 80 power the sample required to carry out the study is 14 patients in each group To compensate for any losses we will increase the sample by 10 leaving 15 volunteers in each group
METHODS Study outcomes Primary outcome Compare the prevalence of a full stomach after fasting for at least 8 hours for solids and 2 hours for clear liquids through gastric ultrasound in volunteers using semaglutide with those who do not use the medication The outcome will be binary a full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 15mlkg It will be considered an empty stomach when no content or clear liquids are visible inferior to 15mlkg
Secondary outcomes
Assess the demographic characteristics of the volunteers
Describe the dose and regimen of medication use
Describe the reason for using the medication
Describe the presence of symptoms such as nausea vomiting and sensation of gastric fullness loss of appetite early satiety and abdominal pain
Describe the use of other medications
Risk factors for bronchoaspiration
Diabetes Mellitus with peripheral neuropathy or history of gastroparesis
Obesity Defined as body mass index BMI inferior to 30 kgm2
Active cancer
Gastroesophageal Reflux Disease
Use of opioids
History of surgery for obesity
Neurological disease
Chronic or acute kidney disease
Symptomatic hypothyroidism
Technical limitation for evaluation of gastric contents by ultrasonography
Previous gastric surgery such as partial gastrectomy or gastric bypass
Massive hiatus hernia
Proper fasting
Fasting will be considered adequate
general diet 8 hours
Clear liquids water juices without lumps 2 hours
Types of GLP-1 analogue
The following drugs will be considered
Semaglutide Ozempic Wegovy
Protocol for performing gastric ultrasonography
It consists of scanning the abdomen in the sagittal plane in the dorsal decubitus position at 45 degrees in the supine position and in the right lateral decubitus position with a curvilinear low-frequency ultrasound probe2 to 5 mHz and locating the gastric antrum through the identification of the main points of reference - left lobe of the liver and a main vessel aorta or inferior vena cava Gastric emptying will be assessed quantitatively and qualitatively through assessment of the composition of its contents and measurement of gastric volume respectively
The qualitative assessment will assess whether the stomach is empty with clear liquid or with solids The stomach is considered empty when the antrum presents itself with the anterior and posterior walls juxtaposed denoting a buffalo eye or target pattern a characteristic attributed by the identification of a hypoechoic thick external ring The antrum may appear empty in the supine position and fluid-filled in the right lateral decubitus position The volume of liquid must be measured in this position and if it is less than 15 mlkg average of 100ml in adults it is considered normal in fasting individuals and the risk of bronchoaspiration is considered low On the other hand the visualization of liquid both in the supine position and in the right lateral decubitus position is suggestive of a large gastric volume When the liquid measurement is greater than 15 mlkg the patient is at high risk for bronchoaspiration
Whenever clear liquids are visualized gastric volume is measured using the cross-sectional area of the gastric antrumAA using the external wall of the stomach which has a linear correlation with gastric volume This is performed in the right lateral decubitus position with two perpendicular diameters of the antrum from serosa to serosa the longitudinal or craniocaudal diameterCC and the anteroposterior diameter AP or using the ellipse formula developed by Bolondi where AACC AP π 4 With the value of π 314 After calculating the AA the total stomach volume predicted volume will be evaluated in each volunteer with a previously tested and validated mathematical model in which the stomach volumeml 27 146 x AA cm2 - 128 age in years
Collected variables Demographic data will be collected Ultrasound images will be registered in the radiology picture archiving and communication system Data will be collected in printed clinical records andor an electronic form specifically developed for the study using the REDCap Research Electronic Data Capture electronic form The authors will be responsible for monitoring the data
Demographic and baseline data
Verification of inclusion and exclusion criteria
Applicability and date of application of the informed consent form
Date of birth
Age in years
Gender
Ethnicity
Weight in kg
Height in cm
BMI in kgm2
Date of inclusion in the study
Data regarding the GLP-1 analogue
Semaglutide
Ozempic
Wegovy
Administration dosage
Time of medication use in months or weeks when time of use is less than 1 month
Previous use of semaglutide
Previous use of another medication from the GLP-1 analogue class
Reason for using the medication
Clinical symptoms of gastroparesis
Nausea
Vomiting
Abdominal pain
Sensation of gastric fullness
Early satiety
Loss of appetite
Use of other medications
Data regarding gastric ultrasound examination
Qualitative check
Full stomach - solid residue or clear liquid volume 15 mlkg
Empty stomach - no content or volume of clear liquid Volume 15 mlkg
STATISTICAL ANALYSIS Included patients will be divided into two groups according to the use or not of Semaglutide and the gastric residue found a full stomach or an empty stomach Differences between groups in relation to continuous numerical variables will be analyzed using the Student t test normal distribution or Mann-Whitney U test variables not normally distributed Proportions will be compared using the Chi-square test or Fishers Exact Test All significance probabilities p values presented will be two-tailed p-values will be considered statistically significant when less than 005 All analyzes will be performed using the software R 341 R Foundation for Statistical Computing Vienna Austria
SAFETY AND ETHICAL CONSIDERATIONS Risks and benefits Abdominal ultrasound is a non-invasive exam that does not emit radiation There is no evidence to support that the use of ultrasound can cause any harm to health The research participant may experience some discomfort related to fasting for 8 hours for solids and 2 hours for liquids
There are risks related to the loss of data confidentiality and the research team is responsible for taking all precautions to ensure data confidentiality
This study may benefit individuals who use this medication when undergoing anesthesia According to the results of this study suspension of this medication preoperatively or other safety measures may be recommended
Approval from ethical and regulatory authorities The study was approved by the Institutional review Board IRB and written consent from the patient will be requested
Data confidentiality The patient will be identified by the corresponding number on the electronic data collection form The data obtained must be kept confidential by the researchers and will be stored on the REDCAP Platform which allows restricted access to information according to security levels and individualized logins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None