Gastric Ultrasound in Pregnant Women at Term

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01564030
First received: March 23, 2012
Last updated: November 8, 2012
Last verified: November 2012

March 23, 2012
November 8, 2012
February 2012
June 2012   (final data collection date for primary outcome measure)
Reliability of the ultrasonographic diagnosis of the gastric status [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01564030 on ClinicalTrials.gov Archive Site
Inter-observer agreement of gastric content diagnosis [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gastric Ultrasound in Pregnant Women at Term
Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
  • Respiratory Aspiration
  • Pregnancy
  • Other: Empty
    overnight fast
  • Other: Fluid
    250mL apple juice
  • Other: Solid
    breakfast
  • Empty stomach
    Patients have fasted for 8 hours.
    Intervention: Other: Empty
  • Fluid
    Patients have fasted for 8 hours, followed by the consumption of 250mL of apple juice.
    Intervention: Other: Fluid
  • Solid
    Patients have fasted for 8 hours, followed by the consumption of their breakfast.
    Intervention: Other: Solid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01564030
12-01
No
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP