Ultrasound Assessment of Gastric Content and Volume

Completed

• Conditions: Fasting

• Registration Number: NCT02810977
• Lead Sponsor: Fundación Santa Fe de Bogota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric content	June to December	Ultrasound assessment of gastric content (empty, fluids, or solid) of patients undergoing surgery after complete fasting (more than 8 hours)
Gastric volume	June to December	Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours)

Secondary Outcome Measures

Name	Time	Method
Association with fasting time	June to December	To identify the association between gastric content and volume and preoperative fasting time.
Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate	June to December	To identify the association between gastric content and volume with conditions such as diabetes, obesity, hiatal hernia, among others.

Trial Locations

Locations (2)

Hospital Universitario Fundacion SantaFe de Bogota; 🇨🇴 Bogota, Colombia

Hospital Universitario San Ignacio; 🇨🇴 Bogota, Colombia