Ultrasound Assessment of Gastric Content and Volume
1 other identifier
observational
1,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMarch 22, 2017
March 1, 2017
6 months
June 17, 2016
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Gastric volume
Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours)
June to December
Secondary Outcomes (2)
Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate
June to December
Association with fasting time
June to December
Interventions
Ultrasound assessment of gastric content and volume
Eligibility Criteria
Men and women 18 years or older requiring surgery with complete preoperative fasting (more than 8 hours but less than 14), ASA I-III.
You may qualify if:
- Adults ≥ 18 years
- perioperative fasting time between 8 and 14 hours
- American Society of Anesthesiologists status I, II, III
- Scheduled surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación Santa Fe de Bogotalead
- Hospital Universitario San Ignaciocollaborator
Study Sites (2)
Hospital Universitario Fundacion SantaFe de Bogota
Bogotá, Bogota D.C., Colombia
Hospital Universitario San Ignacio
Bogotá, Bogota D.C., Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A Valencia, MD
Fundacion Santa Fe de Bogota
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 17, 2016
First Posted
June 23, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
March 22, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share