AspirationNCT02588495
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
A study testing Food intake in people with Aspiration, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspiration
- What is being tested?
- Food intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 26 Oct 2015to Jun 2017
- Phase
- Interventional
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged 18 to 85 years
- Male or female
- American Society of Anesthesia physical status classification I and II
- Height greater than 145 cm
- Ability to understand the study protocol and provide informed consent
Who cannot join
- Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
- History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
Trial locations and contacts
1 site in 1 country.
About this study
During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.
The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.
- Conditions
- Aspiration
- Being tested
- Food intake
- Keywords
- Ultrasound, Gastric area, Accuracy, Aspirate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food intakeOther
Either drinking a cup of clear liquid, or having a cup of coffee and a muffin
| Study group | Role | What they receive |
|---|---|---|
| Fasting | No intervention | Participant will remain fasted following initial gastric ultrasound |
| Food intake | Experimental | Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound Receives: Other: Food intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound's sensitivity to identify a "full stomach"
Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids
Measured: 5 minutes
Secondary outcomes (2)
Ultrasound's accuracy in detecting a "full stomach"
Assessing how accurate the Ultrasound machine is in detecting either liquid or solid contents in the participant's stomach after ingestion
Measured: 5 minutes
Inter/Intra-rater reliability of observer in detecting a "full stomach"
Determining the reliability of observers in being able to similarly detect a full stomach
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start26 Oct 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AspirationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588495
- Sponsor's protocol ID
- 14-7883-BE
- Status last verified
- Nov 2017
- First submitted
- 26 Oct 2015
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PubMed 29624530
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
- ClinicalTrials.gov ID
- NCT02588495
- Acronym / sponsor ID
- 14-7883-BE
- Conditions
- Aspiration
- Keywords
- Ultrasound, Gastric area, Accuracy, Aspirate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Oct 2015 (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.
During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.
The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | No intervention | –Participant will remain fasted following initial gastric ultrasound |
| Food intake | Experimental | Other: Food intakeParticipant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged 18 to 85 years
- Male or female
- American Society of Anesthesia physical status classification I and II
- Height greater than 145 cm
- Ability to understand the study protocol and provide informed consent
Key exclusion criteria (2 listed)
- Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
- History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
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 |
|---|---|---|
| Food intakeEither drinking a cup of clear liquid, or having a cup of coffee and a muffin | Other | Food intake |
Primary outcome
Ultrasound's sensitivity to identify a "full stomach"
Time frame: 5 minutes
Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids
2 secondary outcomes
Ultrasound's accuracy in detecting a "full stomach"
Time frame: 5 minutes
Inter/Intra-rater reliability of observer in detecting a "full stomach"
Time frame: 5 minutes
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 24 Nov 2017.
- Derived from this study: PubMed 29624530Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
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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.
Anahi Perlas, MD principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food intake in people with Aspiration, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 2 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Ultrasound's sensitivity to identify a "full stomach" (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588495, which also lists 1 linked publication.
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 24 Nov 2017.