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Gastric Ultrasound in Pregnant Women at Term

Primary Purpose

Respiratory Aspiration, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Empty
Fluid
Solid
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Aspiration focused on measuring Pregnancy, Respiratory aspiration, Gastric contents, Ultrasound

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Empty stomach

Fluid

Solid

Arm Description

Patients have fasted for 8 hours.

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

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

Outcomes

Primary Outcome Measures

Reliability of the ultrasonographic diagnosis of the gastric status
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

Inter-observer agreement of gastric content diagnosis

Full Information

First Posted
March 23, 2012
Last Updated
November 8, 2012
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01564030
Brief Title
Gastric Ultrasound in Pregnant Women at Term
Official Title
Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Aspiration, Pregnancy
Keywords
Pregnancy, Respiratory aspiration, Gastric contents, Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empty stomach
Arm Type
Other
Arm Description
Patients have fasted for 8 hours.
Arm Title
Fluid
Arm Type
Other
Arm Description
Patients have fasted for 8 hours, followed by the consumption of 250mL of apple juice.
Arm Title
Solid
Arm Type
Other
Arm Description
Patients have fasted for 8 hours, followed by the consumption of their breakfast.
Intervention Type
Other
Intervention Name(s)
Empty
Intervention Description
overnight fast
Intervention Type
Other
Intervention Name(s)
Fluid
Intervention Description
250mL apple juice
Intervention Type
Other
Intervention Name(s)
Solid
Intervention Description
breakfast
Primary Outcome Measure Information:
Title
Reliability of the ultrasonographic diagnosis of the gastric status
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Inter-observer agreement of gastric content diagnosis
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25080428
Citation
Arzola C, Cubillos J, Perlas A, Downey K, Carvalho JC. Interrater reliability of qualitative ultrasound assessment of gastric content in the third trimester of pregnancy. Br J Anaesth. 2014 Dec;113(6):1018-23. doi: 10.1093/bja/aeu257. Epub 2014 Jul 30.
Results Reference
derived

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Gastric Ultrasound in Pregnant Women at Term

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