Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Completed

Conditions: Pregnancy; Respiratory Aspiration

Treatments: Other: water

Study type: Interventional

Funder types: Other

Identifiers

NCT01980108

13-07

Details and patient eligibility

About

Solid food or fluid residue in the stomach is always a major concern when patients need 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 is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.

The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.

Full description

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. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.

In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Volunteer 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

Trial design

60 participants in 6 patient groups

empty stomach

No Intervention group

Description:

No fluid will be given to the patient prior to scanning.

50mL

Experimental group

Description:

50mL of water will be given to the patient prior to scanning

Treatment:

Other: water

100mL

Experimental group

Description:

100mL of water will be given to the patient prior to scanning

Treatment:

Other: water

200mL

Experimental group

Description:

200mL of water will be given to the patient prior to scanning

Treatment:

Other: water

300mL

Experimental group

Description:

300mL of water will be given to the patient prior to scanning

Treatment:

Other: water

400mL

Experimental group

Description:

400mL of water will be given to the patient prior to scanning

Treatment:

Other: water