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
• 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
• 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

Related Conditions & MeSH terms

• Fasting

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