Clinical trial NCT05946447: Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
Official title: Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Respiratory Aspiration of Gastric Content
Keywords: Gastric Ultrasound
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 it's 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.


Eligibility criteria: Inclusion Criteria:

* non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia
* ≥37 weeks gestational age
* ≥18 years of age
* ASA physical status II-III
* weight 50 to 120 kg
* height ≥150 cm
* ability to understand the rationale of the study evaluations.

Exclusion Criteria:

* multiple pregnancy
* known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract
* previous surgical procedures on the esophagus, stomach or upper abdomen
* patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)

Primary outcomes:
measure: Antral cross-sectional area (supine position)
timeFrame: 5 minutes
measure: Antral cross-sectional area (right lateral decubitus)
timeFrame: 5 minutes
Secondary outcomes:
measure: Intra-rater reliability calculation
timeFrame: 5 minutes
measure: Inter-rater reliability calculation
timeFrame: 5 minutes
measure: Grading of stomach contents
timeFrame: 5 minutes
measure: Gastric volume (supine position)
timeFrame: 5 minutes
measure: Gastric volume (right lateral decubitus)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Cristian Arzola, MD
role: PRINCIPAL_INVESTIGATOR
References: