Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621706
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Elective Cesarean Section A Prospective Randomized Clinical Trial
Status:
RECRUITING
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 the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section
Detailed Description:
Fasting is a mandatory requirement prior to elective anesthesia and is intended to reduce gastric fluid volume and the risk of aspiration of gastric contents and subsequent organ injury Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality and its severity depends upon the gastric volume and nature of the aspirate
A high-risk stomach refers to a gastric volume associated with an increased risk of pulmonary aspiration and is defined in most published literature as the presence of any solid or liquid content 15 mLkg Pregnant women have been considered to be at particular risk of aspiration syndromes as a consequence of physiological changes during pregnancy which lead to relaxation of lower oesophageal sphincter and mechanical upward displacement of the stomach by the enlarged uterus
European Society of Anaesthesiology ESA recommends fasting for 2 hours after clear liquids and 6 hours after light meals before elective surgery including in pregnant patients In contrast the American Society of Anesthesiology guidelines specifically exclude pregnant women and the Society for Obstetric Anesthesia and Perinatology taskforce recommended a fasting period of 6-8 hours depending on the nature of food ingested
Diabetic patients can present with diabetic gastropathy an autonomic neuropathy associated with delayed gastric emptying in the absence of gastric outlet obstruction tend predisposing them to increased risk of aspiration as compared to non-diabetic patients
To date standard fasting guidelines for people with diabetes are still up for debate European Society of Anaesthesiology ESA 2011 Fasting guidelines state that diabetic patients can follow the same guidelines as healthy adults While American Society of Anesthesiologists ASA in 2017 fasting guidelines mentioned that the standard eight hours fasting may not apply or may need to be modified for patients with coexisting diseases or conditions that can affect gastric emptying or fluid volume
With the advent of portable ultrasound machines performing point-of-care ultrasound has become relatively easy and feasible Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment It can identify the nature and the volume of the gastric content ie empty clear fluid and solid and when clear fluid is present its volume can be quantified
In this study we will analyse the stomach contents of Non-labouring term pregnant women after six and eight hours of fasting using previously described qualitative and quantitative ultrasonographic assessments
A high-risk stomach refers to a gastric volume associated with an increased risk of pulmonary aspiration and is defined in most published literature as the presence of any solid or liquid content 15 mLkg Pregnant women have been considered to be at particular risk of aspiration syndromes as a consequence of physiological changes during pregnancy which lead to relaxation of lower oesophageal sphincter and mechanical upward displacement of the stomach by the enlarged uterus
European Society of Anaesthesiology ESA recommends fasting for 2 hours after clear liquids and 6 hours after light meals before elective surgery including in pregnant patients In contrast the American Society of Anesthesiology guidelines specifically exclude pregnant women and the Society for Obstetric Anesthesia and Perinatology taskforce recommended a fasting period of 6-8 hours depending on the nature of food ingested
Diabetic patients can present with diabetic gastropathy an autonomic neuropathy associated with delayed gastric emptying in the absence of gastric outlet obstruction tend predisposing them to increased risk of aspiration as compared to non-diabetic patients
To date standard fasting guidelines for people with diabetes are still up for debate European Society of Anaesthesiology ESA 2011 Fasting guidelines state that diabetic patients can follow the same guidelines as healthy adults While American Society of Anesthesiologists ASA in 2017 fasting guidelines mentioned that the standard eight hours fasting may not apply or may need to be modified for patients with coexisting diseases or conditions that can affect gastric emptying or fluid volume
With the advent of portable ultrasound machines performing point-of-care ultrasound has become relatively easy and feasible Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment It can identify the nature and the volume of the gastric content ie empty clear fluid and solid and when clear fluid is present its volume can be quantified
In this study we will analyse the stomach contents of Non-labouring term pregnant women after six and eight hours of fasting using previously described qualitative and quantitative ultrasonographic assessments
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