Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946447
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2023-06-27
Brief Title:
Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia due to the high risk of pulmonary aspiration of the stomach contents This is especially important in emergency procedures when a fasting period could not be observed Pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia and it is associated with morbidity and mortality Information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether its safe to proceed cancel or delay a surgical procedure The ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients However it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus Although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults it remains to be evaluated in pregnant patients Furthermore it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment This study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise The investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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