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Completed

NCT Number: NCT01980121

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

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.

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Key information

Conditions

Respiratory Aspiration Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Respiration Disorders Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ultrasound

Device

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

Primary outcomes

  1. Qualitative assessment of the antrum of the stomach

    Time frame: 10 minutes

    Patients 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 outcomes

  1. Quantitative assessment of the antrum of the stomach

    Time frame: 10 minutes

    Three consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2013
Registry last updated
Jun 19, 2014

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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