- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184532
Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients (gastric US)
June 9, 2017 updated by: Mohamed Ibrahim Elahl, Healthpoint Hospital
To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods.
Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content.
In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting.
The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for elective orthopedic procedures.
Description
Inclusion Criteria:
- Patients scheduled for elective orthopedic procedures.
Exclusion Criteria:
- Patients with BMI > 35 kg.m-2, age <18y, ASA physical state >II, fasting more than 6hs, or with gastric diseases will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
D
diabetic patients
|
ultrasound examination of pyloric antrum
|
ND
non-diabetic patients
|
ultrasound examination of pyloric antrum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gastric volume
Time Frame: bedside test 5 minutes
|
bedside test 5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2017
Primary Completion (Anticipated)
December 15, 2017
Study Completion (Anticipated)
December 31, 2017
Study Registration Dates
First Submitted
June 9, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 12, 2017
Study Record Updates
Last Update Posted (Actual)
June 12, 2017
Last Update Submitted That Met QC Criteria
June 9, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- rec003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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