Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543615
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy Comparative Study With Patients Without History of Bariatric Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy Comparative Study With Patients Without History of Bariatric Surgeries
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
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:
Preoperative US assessment of residual gastric volume in both patients with previous laparoscopic sleeve gastrectomy and those without history of bariatric surgeries undergoing elective laparoscopic cholecystectomy aiming to develop a step for recommendations for fasting guidelines
Detailed Description:
No doubt that perioperative aspiration of gastric content during anesthesia process is every anesthesiologists nightmare which can lead to serious morbidities and mortalities with a rate of 5 to 9 in anesthesia airway management accidents Mark 2021
Risk of aspiration usually present during induction of anesthesia due to passive regurgitation during endotracheal intubation while it may occur during recovery from anesthesia in patients with active vomiting Haitao et al 2023 Kluger et al 1999
It is known that the volume of residual gastric content is one of the most important factors that can lead to significant increase in the risk of perioperative pulmonary aspiration acknowledging this fact lead the American society of Anesthesiology ASA to recommend for eight hours fasting for solids fats andor meats six hours for non-human milk and light meals and two hours for clear fluids to reduce residual gastric volume and subsequently the risk of perioperative aspiration Jeffrey et al 2017
There are many different ways to asses gastric content for example nasogastric tube aspiration of gastric content which is an invasive technique Other ways include imaging tools like abdominal CT scan which is not easily done and will have extra cost on the patient In addition wireless motility capsules and gastric emptying scintigraphy can be used but all of them are not suitable for routine assessment
On the other hand Point-of-Care POC ultrasound usage in anesthesia management has provided a wide range of rapid bed side and non-invasive easy and fast techniques that help to reduce the risk of morbidity and mortality It also helped to provide a technique for qualitative and quantitative assessments of residual gastric contents preoperatively through gastric antrum US assessment using measurement of the antral cross-sectional area François-Pierrick et al 2021
In the past it was believed that gastric content more than 25 mlkg was considered as an at risk stomach volume Czarnetzki et al 2015 but nowadays several studies using ultrasonography assessment of residual gastric content indicated that the accepted volume should be less than 15 mlkg in healthy fasting adult to define an empty stomach Perlas et al 2011 Kruisselbrink et al 2019
It is well known that bariatric surgeries nowadays became very popular among patients suffering from obesity for the sake of better quality of life specially sleeve gastrectomy and Roux-en-Y gastric bypass surgeries A statistical study was done among the American population in 2018 reported that about 252 000 bariatric procedures are being performed every year and the number is rising by time specially with advanced surgical techniques that reduced the complications of these types of surgeries David et al 2020 However no statistics has been released for Egyptian population
As regards Nele et al Nele et al 2022 reported that gastric emptying was significantly reduced in patients with history of sleeve gastrectomy and Roux-en-Y gastric bypass surgeries as compared to obese patients by comparing gastric emptying scintigraphy wireless motility capsule and gastrointestinal fluid aspiration techniques
Also Eric et al Eric et al 2019 in their meta-analysis study have reported that gastric emptying time was reduced after gastric bypass surgery but it was constant or increased with endoscopically inserted intragastric balloons
Many studies tried to asses changes in GIT physiology after bariatric surgeries including gastric emptying time using several methods as mentioned before but less frequently ultrasound guided assessment
Risk of aspiration usually present during induction of anesthesia due to passive regurgitation during endotracheal intubation while it may occur during recovery from anesthesia in patients with active vomiting Haitao et al 2023 Kluger et al 1999
It is known that the volume of residual gastric content is one of the most important factors that can lead to significant increase in the risk of perioperative pulmonary aspiration acknowledging this fact lead the American society of Anesthesiology ASA to recommend for eight hours fasting for solids fats andor meats six hours for non-human milk and light meals and two hours for clear fluids to reduce residual gastric volume and subsequently the risk of perioperative aspiration Jeffrey et al 2017
There are many different ways to asses gastric content for example nasogastric tube aspiration of gastric content which is an invasive technique Other ways include imaging tools like abdominal CT scan which is not easily done and will have extra cost on the patient In addition wireless motility capsules and gastric emptying scintigraphy can be used but all of them are not suitable for routine assessment
On the other hand Point-of-Care POC ultrasound usage in anesthesia management has provided a wide range of rapid bed side and non-invasive easy and fast techniques that help to reduce the risk of morbidity and mortality It also helped to provide a technique for qualitative and quantitative assessments of residual gastric contents preoperatively through gastric antrum US assessment using measurement of the antral cross-sectional area François-Pierrick et al 2021
In the past it was believed that gastric content more than 25 mlkg was considered as an at risk stomach volume Czarnetzki et al 2015 but nowadays several studies using ultrasonography assessment of residual gastric content indicated that the accepted volume should be less than 15 mlkg in healthy fasting adult to define an empty stomach Perlas et al 2011 Kruisselbrink et al 2019
It is well known that bariatric surgeries nowadays became very popular among patients suffering from obesity for the sake of better quality of life specially sleeve gastrectomy and Roux-en-Y gastric bypass surgeries A statistical study was done among the American population in 2018 reported that about 252 000 bariatric procedures are being performed every year and the number is rising by time specially with advanced surgical techniques that reduced the complications of these types of surgeries David et al 2020 However no statistics has been released for Egyptian population
As regards Nele et al Nele et al 2022 reported that gastric emptying was significantly reduced in patients with history of sleeve gastrectomy and Roux-en-Y gastric bypass surgeries as compared to obese patients by comparing gastric emptying scintigraphy wireless motility capsule and gastrointestinal fluid aspiration techniques
Also Eric et al Eric et al 2019 in their meta-analysis study have reported that gastric emptying time was reduced after gastric bypass surgery but it was constant or increased with endoscopically inserted intragastric balloons
Many studies tried to asses changes in GIT physiology after bariatric surgeries including gastric emptying time using several methods as mentioned before but less frequently ultrasound guided assessment
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