FastingNCT02810977
Ultrasound Assessment of Gastric Content and Volume
An observational study of Fasting, run by Fundación Santa Fe de Bogota at 2 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesColombia
- Study dates
- Jun 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults ≥ 18 years
- perioperative fasting time between 8 and 14 hours
- American Society of Anesthesiologists status I, II, III
- Scheduled surgery
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Hospital Universitario Fundacion SantaFe de Bogota
Bogotá, Bogota D.C.
Hospital Universitario San Ignacio
Bogotá, Bogota D.C.
About this study
Official title: Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study
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.
- Conditions
- Fasting
- Being tested
- Ultrasound
- Keywords
- gastric volume, gastric content, ultrasound, perioperative fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound assessment of gastric content and volume
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric content
Ultrasound assessment of gastric content (empty, fluids, or solid) of patients undergoing surgery after complete fasting (more than 8 hours)
Measured: June to December
Gastric volume
Ultrasound assessment of gastric volume (in milliliters) of patients undergoing surgery after complete fasting (more than 8 hours)
Measured: June to December
Secondary outcomes (2)
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.
Measured: June to December
Association with fasting time
To identify the association between gastric content and volume and preoperative fasting time.
Measured: June to December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Ignacio
- Responsible party
- Principal investigator, Jose Alejandro Valencia, Fundación Santa Fe de Bogota
- Investigators
- Jose A Valencia, MD, Principal investigator, Fundacion Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810977
- Sponsor's protocol ID
- CCEI-5325-2016
- Status last verified
- Mar 2017
- First submitted
- 17 Jun 2016
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Content and Volume After Complete Fasting in Patients Undergoing Surgery at Two University Hospitals: A Multicentric Study
- ClinicalTrials.gov ID
- NCT02810977
- Acronym / sponsor ID
- CCEI-5325-2016
- Conditions
- Fasting
- Keywords
- gastric volume, gastric content, ultrasound, perioperative fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Collaborators
- Hospital Universitario San Ignacio
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- perioperative fasting time between 8 and 14 hours
- American Society of Anesthesiologists status I, II, III
- Scheduled surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound assessment of gastric content and volume | Device | – |
Primary outcome
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)
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)
2 secondary outcomes
Association of gastric content and volume with special conditions as assessed by Anova or Kruskal as appropriate
Time frame: June to December
Association with fasting time
Time frame: June to December
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Valencia, MD principal investigator
Fundacion Santa Fe de Bogota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, run by Fundación Santa Fe de Bogota at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric content (time frame: June to December). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.