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NCT02810977 Clinical Trial

Ultrasound Assessment of Gastric Content and Volume

Fasting Clinical Trial

Official title:
Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02810977
Other study ID # CCEI-5325-2016
Secondary ID
Status Completed
Phase N/A
First received June 17, 2016
Last updated March 21, 2017
Start date June 2016
Est. completion date January 2017

Study information
Verified date March 2017
Source Fundación Santa Fe de Bogota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anesthesiologists try to avoid complications with significant peri -operative morbidity and mortality such as bronchoaspiration in patients requiring a surgical procedure under anesthesia. Currently, this is achieved based on experts recommendations from the American Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment of gastric content and volume. This tool allows to individualize each patient and base the decisions objectively. The investigators will assess gastric content and volume by ultrasound in patients who have fasted and require surgery at two University Hospitals.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults = 18 years

- perioperative fasting time between 8 and 14 hours

- American Society of Anesthesiologists status I, II, III

- Scheduled surgery

Exclusion Criteria:

- Abdominal pathology surgical emergency

- Unable to adopt right lateral decubitus position

- Altered gastrointestinal tract anatomy excluding hiatal hernia

- Body mass index greater than 40

- Patients on enteral nutrition probe or with nasogastric probe

- Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ultrasound
Ultrasound assessment of gastric content and volume

Locations
Country Name City State
Colombia Hospital Universitario Fundacion SantaFe de Bogota Bogota
Colombia Hospital Universitario San Ignacio Bogota

Sponsors (2)
Lead Sponsor Collaborator
Fundación Santa Fe de Bogota Hospital Universitario San Ignacio

Country where clinical trial is conducted

Colombia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric content Ultrasound assessment of gastric content (empty, fluids, or solid) of patients undergoing surgery after complete fasting (more than 8 hours) June to December
Primary Gastric volume Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours) June to December
Secondary Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate To identify the association between gastric content and volume with conditions such as diabetes, obesity, hiatal hernia, among others. June to December
Secondary Association with fasting time To identify the association between gastric content and volume and preoperative fasting time. June to December
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