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CompletedNCT02810977Updated Mar 22, 2017

Ultrasound Assessment of Gastric Content and Volume

An observational study in Fasting, sponsored by Fundación Santa Fe de Bogota. Completed at 2 sites in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Fundación Santa Fe de Bogota · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fasting

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Keywords

  • gastric volume
  • gastric content
  • ultrasound
  • perioperative fasting
03

In context

Fasting

87 studies on the registry are indexed under Fasting; 38 are open to participants now.

This study's enrollment of 1,000 is above the median of 100 across 21 observational studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Fundación Santa Fe de Bogota is the lead sponsor of 27 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Men and women 18 years or older requiring surgery with complete preoperative fasting (more than 8 hours but less than 14), ASA I-III.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,000 participants (actual)
Patient registry
No

Interventions

  • DeviceUltrasound

    Ultrasound assessment of gastric content and volume

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What researchers measure

Primary outcomes

  1. Gastric content

    Ultrasound assessment of gastric content (empty, fluids, or solid) of patients undergoing surgery after complete fasting (more than 8 hours)

    Time frame: June to December

  2. Gastric volume

    Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours)

    Time frame: June to December

Secondary outcomes

  1. 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.

    Time frame: June to December

  2. Association with fasting time

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

    Time frame: June to December

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Study locations

2 sites
  • Hospital Universitario Fundacion SantaFe de Bogota
    Bogotá, Bogota D.C., Colombia
  • Hospital Universitario San Ignacio
    Bogotá, Bogota D.C., Colombia
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2016, a primary completion of Dec 2016 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2016
First posted
Jun 23, 2016
Start
Jun 2016
Primary completionActual
Dec 2016
CompletionActual
Jan 2017
Last update
Mar 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02810977
Lead sponsor
Fundación Santa Fe de Bogota
Collaborators
Hospital Universitario San Ignacio
Responsible party
Jose Alejandro Valencia (MD, Fundación Santa Fe de Bogota) — Principal investigator
First posted
Jun 23, 2016
Start date
Jun 2016
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Mar 22, 2017

Study contacts

Jose A Valencia, MD
principal investigator · Fundacion Santa Fe de Bogota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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