Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606782
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Incidence of Stomach Fullness and Associated Factors in Elective Surgical Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Incidence of Stomach Fullness in Elective Surgical Patients and Investigation of Associated Factors Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this prospective observational study is to evaluate the incidence of residual gastric content in elective surgical patients who adhered to preoperative fasting guidelines and to investigate associated patient-related factors Ultrasound USG has been identified as a valuable tool for assessing residual gastric content and this study compares its efficacy against traditional questionnaire-based predictions The study also examines the practicality and accuracy of different gastric volume estimation formulas and evaluates their correlation with aspiration risk
A total of 475 patients were enrolled in the study of whom 404 completed both the questionnaire and USG examination All participants were adult patients scheduled for elective surgery following standard fasting protocols The ultrasound examination assessed the presence of solid or fluid content in the stomach and patients were classified according to qualitative Perlas risk scores Grade 0 Low Grade 1 Moderate Grade 2 High risk of aspiration The questionnaire collected patient-reported factors such as symptoms of early satiety history of cholelithiasis and comorbidities like diabetes or chronic obstructive pulmonary disease COPD
The primary objective of this study was to evaluate the efficacy of USG in detecting residual gastric content and compare it with questionnaire-based risk predictions Logistic regression analysis identified early satiety and cholelithiasis as significant predictors of a full stomach and higher aspiration risk Fasting duration was found to have a protective effect reducing the likelihood of a full stomach While many patient characteristics traditionally associated with delayed gastric emptying such as age and diabetes did not significantly correlate with the outcomes early satiety and cholelithiasis proved to be key factors influencing gastric content
In addition this study explored the performance of several gastric volume estimation formulas including the Michiko Bouvet and Perlas 20192020 formulas The findings indicated significant limitations in these formulas with many patients being estimated to have negative gastric volumes particularly by the Michiko and two of Perlasamp39 formulas This highlights the inadequacies of current formulas in accurately predicting gastric volume necessitating further refinement and development of new models that better account for physiological variability
Furthermore the agreement between questionnaire-based predictions and USG findings was assessed using Cohens Kappa which indicated fair agreement Kappa value 0282 This suggests that while the questionnaire can serve as a screening tool to identify patients at risk of aspiration it cannot replace the accuracy and reliability of USG in clinical practice
Secondary objectives of the study included comparing the time-efficiency and ease of implementation between USG and the questionnaire-based assessments USG proved to be more time-efficient taking an average of 25 minutes per examination compared to 3-5 minutes for completing the questionnaire This speed combined with its objective nature underscores USGs value as a practical tool in the preoperative setting
In conclusion USG was found to be an effective and efficient tool for assessing residual gastric content and predicting aspiration risk outperforming traditional questionnaire-based assessments The inadequacy of current gastric volume estimation formulas points to the need for further research to develop more accurate and context-specific assessment tools Comprehensive preoperative evaluation incorporating USG and patient-reported symptoms may improve patient safety by reducing the risk of aspiration during elective surgery
A total of 475 patients were enrolled in the study of whom 404 completed both the questionnaire and USG examination All participants were adult patients scheduled for elective surgery following standard fasting protocols The ultrasound examination assessed the presence of solid or fluid content in the stomach and patients were classified according to qualitative Perlas risk scores Grade 0 Low Grade 1 Moderate Grade 2 High risk of aspiration The questionnaire collected patient-reported factors such as symptoms of early satiety history of cholelithiasis and comorbidities like diabetes or chronic obstructive pulmonary disease COPD
The primary objective of this study was to evaluate the efficacy of USG in detecting residual gastric content and compare it with questionnaire-based risk predictions Logistic regression analysis identified early satiety and cholelithiasis as significant predictors of a full stomach and higher aspiration risk Fasting duration was found to have a protective effect reducing the likelihood of a full stomach While many patient characteristics traditionally associated with delayed gastric emptying such as age and diabetes did not significantly correlate with the outcomes early satiety and cholelithiasis proved to be key factors influencing gastric content
In addition this study explored the performance of several gastric volume estimation formulas including the Michiko Bouvet and Perlas 20192020 formulas The findings indicated significant limitations in these formulas with many patients being estimated to have negative gastric volumes particularly by the Michiko and two of Perlasamp39 formulas This highlights the inadequacies of current formulas in accurately predicting gastric volume necessitating further refinement and development of new models that better account for physiological variability
Furthermore the agreement between questionnaire-based predictions and USG findings was assessed using Cohens Kappa which indicated fair agreement Kappa value 0282 This suggests that while the questionnaire can serve as a screening tool to identify patients at risk of aspiration it cannot replace the accuracy and reliability of USG in clinical practice
Secondary objectives of the study included comparing the time-efficiency and ease of implementation between USG and the questionnaire-based assessments USG proved to be more time-efficient taking an average of 25 minutes per examination compared to 3-5 minutes for completing the questionnaire This speed combined with its objective nature underscores USGs value as a practical tool in the preoperative setting
In conclusion USG was found to be an effective and efficient tool for assessing residual gastric content and predicting aspiration risk outperforming traditional questionnaire-based assessments The inadequacy of current gastric volume estimation formulas points to the need for further research to develop more accurate and context-specific assessment tools Comprehensive preoperative evaluation incorporating USG and patient-reported symptoms may improve patient safety by reducing the risk of aspiration during elective surgery
Detailed Description:
This study is a prospective observational research project designed to evaluate the incidence of residual gastric content in patients scheduled for elective surgery and to investigate patient-related factors that influence gastric emptying The study primarily employs ultrasonography USG as a tool for assessing the presence of residual gastric content and compares its efficacy with traditional questionnaire-based assessments Additionally the study examines the utility and accuracy of various gastric volume estimation formulas assessing their correlation with observed gastric content and aspiration risk
Study Design
Participants were enrolled based on pre-defined inclusion and exclusion criteria including adult patients scheduled for elective surgery who adhered to standard preoperative fasting guidelines Following a detailed informed consent process patients were asked to complete a preoperative questionnaire which gathered data on demographic characteristics medical history and patient-reported symptoms such as early satiety history of cholelithiasis and other relevant comorbidities Ultrasound examinations were performed by a single trained investigator to ensure consistency in imaging and interpretation
USG was utilized to assess residual gastric content including both solid and fluid content The antrum cross-sectional area was measured in the supine and right lateral decubitus positions and gastric volume was estimated using four different formulas Michiko Bouvet two fo Perlas39 formulas developed in differnet investigations Patients were classified into three groups according to the Perlas risk score which is based on ultrasound findings of gastric content Grade 0 low risk Grade 1 moderate risk Grade 2 high risk of aspiration The primary outcome was the identification of a full stomach defined as the presence of solid content or fluid contentbased on ultrasound findings
Registry Procedures and Quality Control
Quality assurance procedures were integrated into the study to ensure the reliability of both questionnaire-based data and ultrasound findings The following processes were implemented
1 Data Validation All questionnaire responses and ultrasound measurements were reviewed for consistency and completeness In the event of data entry errors or inconsistencies the original data sources questionnaires or ultrasound logs were consulted for clarification and correction
2 Source Data Verification Ultrasound findings were periodically cross-referenced with patient charts and medical records to verify the accuracy of reported comorbidities and other patient characteristics
3 Data Dictionary and Coding The study utilized a detailed data dictionary for all variables including categorical coding for risk factors comorbidities and ultrasound findings For example the World Health Organizations MedDRA coding was used for medical conditions and normal ranges for fasting times and antrum cross-sectional area were predefined based on existing literature
4 Standard Operating Procedures SOPs SOPs were developed for patient recruitment ultrasound measurements data collection data management and data analysis These procedures included regular checks for missing or incomplete data predefined criteria for image quality in ultrasound readings and protocols for identifying and addressing any out-of-range results
Sample Size Assessment
A sample size of 207 patients was calculated using the G-Power program version 3197 with the degrees of freedom set to 3 and an effect size of 03 This sample size was based on examining two patient groups with a categorical variable containing four categories with a type I error rate of 005 and a type II error rate of 01 To account for subgroup analyses and potential registration errors a target of at least 300 patients was set The final number of patients completing both the questionnaire and ultrasound was 404
Plan for Missing Data
To address missing data the following strategies were implemented
Any incomplete questionnaire responses were flagged and patients were contacted to complete the missing information where possible
Missing ultrasound measurements were rare but if ultrasound images were deemed inadequate eg poor image quality or patient inability to tolerate positioning these patients were excluded from the specific analyses
For missing or inconsistent values a complete-case analysis was employed excluding individuals from specific models if key variables were not available
Sensitivity analyses were conducted to assess the impact of missing data on the final results
Statistical Analysis Plan
Data analysis was conducted using R statistical software version 412 Statistical techniques were selected based on the study objectives
1 Primary Objective USG Efficacy
Logistic regression models were employed to assess the relationship between patient characteristics eg early satiety cholelithiasis and full stomach based on USG findings The dependent variable was the binary outcome of full stomach vs empty stomach
Qualitative scoring based on the Perlas risk score was incorporated to evaluate aspiration risk with separate logistic models developed to predict Grade 0 low risk Grade 1 moderate risk and Grade 2 high risk
Model performance was assessed using the area under the receiver operating characteristic ROC curve AUC and the optimal cutoff points were determined using Youdens index to balance sensitivity and specificity
2 Secondary Objective Questionnaire vs USG
Cohens Kappa statistic was used to assess agreement between questionnaire-based predictions and USG findings This analysis aimed to determine how well the questionnaire could predict residual gastric content and aspiration risk compared to USG
Time-efficiency was analyzed by comparing the average duration of completing the questionnaire 3-5 minutes vs the ultrasound examination 25 minutes
3 Gastric Volume Estimation Formulas
Correlation coefficients Spearmans rank were calculated to determine the association between estimated gastric volumes from the four formulas Michiko Bouvet two of Perlas39 formulas and the ultrasound findings full stomach and aspiration risk
Logistic regression models were developed to evaluate whether the estimated gastric volumes from each formula were significant predictors of full stomach or aspiration risk Negative or non-significant results were flagged as indicators of formula limitations
4 Adjusted Models
Multivariate models adjusting for potential confounders eg age sex comorbidities such as diabetes were developed to ensure that observed associations between patient characteristics and gastric content or risk were not confounded by other variables
A complete-case analysis was performed for all multivariate models excluding patients with missing values for any of the key variables
Limitations
The study acknowledges several limitations First no direct measurement of gastric volume was obtained through orogastric tube aspiration limiting the ability to definitively compare USG findings to a gold standard Second the analysis was constrained by the relatively small number of patients n 57 for whom volume estimation was possible particularly due to negative or invalid results from the gastric volume formulas Lastly the study was performed in a single center and all ultrasound measurements were conducted by a single investigator which while minimizing inter-operator variability may limit the generalizability of the findings to other settings
Future Directions
Future studies should focus on refining the gastric volume estimation formulas and exploring additional patient-reported symptoms and clinical factors that may affect gastric emptying There is also a need to standardize ultrasound protocols and validate the findings in a multi-center diverse patient population In addition comparisons with other preoperative risk assessment tools such as orogastric tube suction should be explored
Study Design
Participants were enrolled based on pre-defined inclusion and exclusion criteria including adult patients scheduled for elective surgery who adhered to standard preoperative fasting guidelines Following a detailed informed consent process patients were asked to complete a preoperative questionnaire which gathered data on demographic characteristics medical history and patient-reported symptoms such as early satiety history of cholelithiasis and other relevant comorbidities Ultrasound examinations were performed by a single trained investigator to ensure consistency in imaging and interpretation
USG was utilized to assess residual gastric content including both solid and fluid content The antrum cross-sectional area was measured in the supine and right lateral decubitus positions and gastric volume was estimated using four different formulas Michiko Bouvet two fo Perlas39 formulas developed in differnet investigations Patients were classified into three groups according to the Perlas risk score which is based on ultrasound findings of gastric content Grade 0 low risk Grade 1 moderate risk Grade 2 high risk of aspiration The primary outcome was the identification of a full stomach defined as the presence of solid content or fluid contentbased on ultrasound findings
Registry Procedures and Quality Control
Quality assurance procedures were integrated into the study to ensure the reliability of both questionnaire-based data and ultrasound findings The following processes were implemented
1 Data Validation All questionnaire responses and ultrasound measurements were reviewed for consistency and completeness In the event of data entry errors or inconsistencies the original data sources questionnaires or ultrasound logs were consulted for clarification and correction
2 Source Data Verification Ultrasound findings were periodically cross-referenced with patient charts and medical records to verify the accuracy of reported comorbidities and other patient characteristics
3 Data Dictionary and Coding The study utilized a detailed data dictionary for all variables including categorical coding for risk factors comorbidities and ultrasound findings For example the World Health Organizations MedDRA coding was used for medical conditions and normal ranges for fasting times and antrum cross-sectional area were predefined based on existing literature
4 Standard Operating Procedures SOPs SOPs were developed for patient recruitment ultrasound measurements data collection data management and data analysis These procedures included regular checks for missing or incomplete data predefined criteria for image quality in ultrasound readings and protocols for identifying and addressing any out-of-range results
Sample Size Assessment
A sample size of 207 patients was calculated using the G-Power program version 3197 with the degrees of freedom set to 3 and an effect size of 03 This sample size was based on examining two patient groups with a categorical variable containing four categories with a type I error rate of 005 and a type II error rate of 01 To account for subgroup analyses and potential registration errors a target of at least 300 patients was set The final number of patients completing both the questionnaire and ultrasound was 404
Plan for Missing Data
To address missing data the following strategies were implemented
Any incomplete questionnaire responses were flagged and patients were contacted to complete the missing information where possible
Missing ultrasound measurements were rare but if ultrasound images were deemed inadequate eg poor image quality or patient inability to tolerate positioning these patients were excluded from the specific analyses
For missing or inconsistent values a complete-case analysis was employed excluding individuals from specific models if key variables were not available
Sensitivity analyses were conducted to assess the impact of missing data on the final results
Statistical Analysis Plan
Data analysis was conducted using R statistical software version 412 Statistical techniques were selected based on the study objectives
1 Primary Objective USG Efficacy
Logistic regression models were employed to assess the relationship between patient characteristics eg early satiety cholelithiasis and full stomach based on USG findings The dependent variable was the binary outcome of full stomach vs empty stomach
Qualitative scoring based on the Perlas risk score was incorporated to evaluate aspiration risk with separate logistic models developed to predict Grade 0 low risk Grade 1 moderate risk and Grade 2 high risk
Model performance was assessed using the area under the receiver operating characteristic ROC curve AUC and the optimal cutoff points were determined using Youdens index to balance sensitivity and specificity
2 Secondary Objective Questionnaire vs USG
Cohens Kappa statistic was used to assess agreement between questionnaire-based predictions and USG findings This analysis aimed to determine how well the questionnaire could predict residual gastric content and aspiration risk compared to USG
Time-efficiency was analyzed by comparing the average duration of completing the questionnaire 3-5 minutes vs the ultrasound examination 25 minutes
3 Gastric Volume Estimation Formulas
Correlation coefficients Spearmans rank were calculated to determine the association between estimated gastric volumes from the four formulas Michiko Bouvet two of Perlas39 formulas and the ultrasound findings full stomach and aspiration risk
Logistic regression models were developed to evaluate whether the estimated gastric volumes from each formula were significant predictors of full stomach or aspiration risk Negative or non-significant results were flagged as indicators of formula limitations
4 Adjusted Models
Multivariate models adjusting for potential confounders eg age sex comorbidities such as diabetes were developed to ensure that observed associations between patient characteristics and gastric content or risk were not confounded by other variables
A complete-case analysis was performed for all multivariate models excluding patients with missing values for any of the key variables
Limitations
The study acknowledges several limitations First no direct measurement of gastric volume was obtained through orogastric tube aspiration limiting the ability to definitively compare USG findings to a gold standard Second the analysis was constrained by the relatively small number of patients n 57 for whom volume estimation was possible particularly due to negative or invalid results from the gastric volume formulas Lastly the study was performed in a single center and all ultrasound measurements were conducted by a single investigator which while minimizing inter-operator variability may limit the generalizability of the findings to other settings
Future Directions
Future studies should focus on refining the gastric volume estimation formulas and exploring additional patient-reported symptoms and clinical factors that may affect gastric emptying There is also a need to standardize ultrasound protocols and validate the findings in a multi-center diverse patient population In addition comparisons with other preoperative risk assessment tools such as orogastric tube suction should be explored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None