Ultrasound Assessment of Gastric Content and Volume

• Sponsor: Fundación Santa Fe de Bogota (Other)
• Overall Status: Completed
• CT.gov ID: NCT02810977
• Collaborator: Hospital Universitario San Ignacio (Other)
• Enrollment: 1,000
• Locations: 2
• Duration (Months): 7
• Patients Per Site: 500
• Patients Per Site Per Month: 71.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fasting	Device: Ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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

1. 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.

2. Association with fasting time [June to December]

   To identify the association between gastric content and volume and preoperative fasting time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Fundacion SantaFe de Bogota	Bogota		Colombia
2	Hospital Universitario San Ignacio	Bogota		Colombia

Sponsors and Collaborators

• Fundación Santa Fe de Bogota
• Hospital Universitario San Ignacio

Investigators

• Principal Investigator: Jose A Valencia, MD, Fundacion Santa Fe de Bogota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jose Alejandro Valencia, MD, Fundación Santa Fe de Bogota
• ClinicalTrials.gov Identifier: NCT02810977
• Other Study ID Numbers: CCEI-5325-2016
• First Posted: Jun 23, 2016
• Last Update Posted: Mar 22, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jose Alejandro Valencia, MD, Fundación Santa Fe de Bogota: gastric volume; gastric content; ultrasound; perioperative fasting

Study Results

No Results Posted as of Mar 22, 2017