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
Verified date | March 2017 |
Source | Fundación Santa Fe de Bogota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Hospital Universitario Fundacion SantaFe de Bogota | Bogota | |
Colombia | Hospital Universitario San Ignacio | Bogota |
Lead Sponsor | Collaborator |
---|---|
Fundación Santa Fe de Bogota | Hospital Universitario San Ignacio |
Colombia,
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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