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Completed

NCT Number: NCT02810977

Ultrasound Assessment of Gastric Content and Volume

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.

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Key information

Conditions

Fasting Behavior Feeding Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Fundacion SantaFe de Bogota, Bogotá, Bogota D.C., Colombia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

Ultrasound assessment of gastric content and volume

Primary outcomes

  1. Gastric content

    Time frame: 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

    Time frame: June to December

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

Secondary outcomes

  1. Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate

    Time frame: 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

    Time frame: June to December

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

Sponsors and collaborators

Lead sponsor

Fundación Santa Fe de Bogota

Other

Collaborators

  • Hospital Universitario San Ignacio

Registry information

Official study title

Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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