NCT05946447

Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery

Completed NA Last updated 23 February 2024

What this trial tests

NA trial testing Ultrasound in Pregnancy in 30 participants. Completed in 30 October 2023.

Timeline

20 July 2023

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	20 July 2023
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	1 location across Canada

Drugs / interventions tested

• Ultrasound

Conditions studied

• Pregnancy — all drugs for Pregnancy →
• Respiratory Aspiration of Gastric Content — all drugs for Respiratory Aspiration of Gastric Content →

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Who can join

Adults 18 to 50, female only, with Pregnancy or Respiratory Aspiration of Gastric Content. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.