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Gastric Ultrasound in Pregnant Women at Term

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01564030
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : November 12, 2012
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Aspiration Pregnancy Other: Empty Other: Fluid Other: Solid Not Applicable

Detailed 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 fo 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, fluid (250 mL of apple juice before scanning) or solid (full breakfast). Their gastric contents are then assessed by 3 different anesthesiologists, using ultrasound. At the end of the scanning, the true stomach contents are revealed. The ability of the assessors to accurately predict stomach contents, as well as the inter-observer agreement, will be examined.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term
Study Start Date : February 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Empty stomach
Patients have fasted for 8 hours.
Other: Empty
overnight fast

Patients have fasted for 8 hours, followed by the consumption of 250mL of apple juice.
Other: Fluid
250mL apple juice

Patients have fasted for 8 hours, followed by the consumption of their breakfast.
Other: Solid

Primary Outcome Measures :
  1. Reliability of the ultrasonographic diagnosis of the gastric status [ Time Frame: 30 minutes ]
    Three physicians trained in gastric ultrasound will be blinded to the treatment group the patient was in, perform an ultrasound, and try to guess whether the patient has an empty stomach, consumed fluids only, or consumed a full meal.

Secondary Outcome Measures :
  1. Inter-observer agreement of gastric content diagnosis [ Time Frame: 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Volunteer non-laboring pregnant women >32 weeks gestation
  • 18 years or older
  • ASA status I-III
  • Weigh between 50 and 120kg
  • Height at least 150cm or taller
  • Written informed consent

Exclusion Criteria:

  • Known pre-existing abnormal anatomy of the upper GI tract
  • Protocol violation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01564030

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Identifier: NCT01564030    
Other Study ID Numbers: 12-01
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Respiratory aspiration
Gastric contents
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes