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Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery

Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery: a Prospective Descriptive Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01980121
Enrollment
103
Registered
2013-11-08
Start date
2013-10-31
Completion date
2014-05-31
Last updated
2014-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Respiratory Aspiration

Keywords

Respiratory Aspiration, Pregnancy, Ultrasound, Gastric Contents

Brief summary

Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. In pregnant patients scheduled for elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A bedside ultrasound assessment of the status of the gastric content and volume would be of great value for the clinician. This technique has recently been shown very promising in fasted non-pregnant patients scheduled for elective surgery. Therefore, it is important to study its feasibility in the pregnant population scheduled for elective Cesarean Delivery. The investigators hypothesize that no residual solid contents will be found in the gastric sonography, and a small volume of gastric fluid will be observed in the antrum in both supine and right lateral decubitus.

Detailed description

The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted pregnant undergoing elective Cesarean delivery. The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.

Interventions

DEVICEUltrasound

Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Non-labouring pregnant women at term (≥ 36 weeks) * 18 years or older * ASA Physical Status I-III * 50-120 kg of weight * 150 cm of height or taller * Ability to understand the rationale of the study assessments and to provide signed informed consent * Written informed consent

Exclusion criteria

* Known pre-existing abnormal anatomy of the upper gastrointestinal tract * History of upper GI tract surgical procedure

Design outcomes

Primary

MeasureTime frameDescription
Qualitative assessment of the antrum of the stomach10 minutesPatients will be classified as follows; Grade 0: the antrum appears empty on both supine and right lateral decubitus positions; grade 1: gastric fluid is visible on the right lateral decubitus position only, suggesting a small fluid volume; and grade 2: gastric fluid is observed in the antrum in both supine and right lateral decubitus, suggesting a larger fluid volume.

Secondary

MeasureTime frameDescription
Quantitative assessment of the antrum of the stomach10 minutesThree consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026