Gastric Ultrasound in Pregnant Women at Term

NCT01564030 | Completed

• 1 other identifier: 12-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Aspiration; Pregnancy

Keywords

Pregnancy; Respiratory aspiration; Gastric contents; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes

Secondary Outcomes (1)

• Inter-observer agreement of gastric content diagnosis

  30 minutes

Study Arms (3)

Empty stomach

OTHER

Patients have fasted for 8 hours.

Other: Empty

Fluid

OTHER

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

Other: Fluid

Solid

OTHER

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

Other: Solid

Interventions

Empty OTHER

overnight fast

Empty stomach

Fluid OTHER

250mL apple juice

Fluid

Solid OTHER

breakfast

Solid

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 25080428 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Fluid Therapy; Polymethyl Methacrylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Methylmethacrylates; Polymethacrylic Acids; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Acrylic Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

CA (1)