MedDataX Logo

Gastric Ultrasound in Pregnant Women at Term

NCT ID: NCT01564030

Last Updated: 2012-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Aspiration Pregnancy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pregnancy Respiratory aspiration Gastric contents Ultrasound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Empty stomach

Patients have fasted for 8 hours.

Group Type OTHER

Empty

Intervention Type OTHER

overnight fast

Fluid

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

Group Type OTHER

Fluid

Intervention Type OTHER

250mL apple juice

Solid

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

Group Type OTHER

Solid

Intervention Type OTHER

breakfast

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empty

overnight fast

Intervention Type OTHER

Fluid

250mL apple juice

Intervention Type OTHER

Solid

breakfast

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25080428 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-01

Identifier Type: -

Identifier Source: org_study_id