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Completed

NCT Number: NCT05946447

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ultrasound

Device

The gastric antrum will be scanned using ultrasound.

Other names: Gastric Ultrasound

Primary outcomes

  1. Antral cross-sectional area (supine position)

    Time frame: 5 minutes

    The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in supine position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.

  2. Antral cross-sectional area (right lateral decubitus)

    Time frame: 5 minutes

    The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in right lateral decubitus position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.

Secondary outcomes

  1. Intra-rater reliability calculation

    Time frame: 5 minutes

    Intra-rater reliability will be calculated using the 3 measurements, for each rater.

  2. Inter-rater reliability calculation

    Time frame: 5 minutes

    Inter-rater reliability will be calculated using the 3 measurements, between raters.

  3. Grading of stomach contents

    Time frame: 5 minutes

    Grading scale: grade 0 means no gastric contents are visualized in supine and the right lateral decubitus, grade 1 means gastric contents are visualized in right lateral decubitus but not in supine decubitus, and grade 2 means gastric contents are visualized in both positions

  4. Gastric volume (supine position)

    Time frame: 5 minutes

    Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in supine position

  5. Gastric volume (right lateral decubitus)

    Time frame: 5 minutes

    Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in right lateral decubitus.

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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