DiabetesNCT02888951
Gastric Ultrasound of Diabetic and Non-Diabetic Patients Following Preoperative Fasting Instructions
An observational study of Diabetes and Diabetes Mellitus, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Diabetes Mellitus Type 1
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Jan 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be patients whom are scheduled to undergo elective surgical procedures requiring preoperative fasting period of at least 8 hours. 240 patients will be recruited in total. One cohort consisting 120 patients will be diabetic (type 1 or 2). The other cohort consisting of 120 patients will be non-diabetic.
Who may be able to join
- Patients scheduled for elective surgery aged 18 to 85 years
- American Society of Anesthesia physical status classification I to III
- Body mass index < 40 kg/ cm2.
Who cannot join
- Pregnancy (currently or within the past 3 months)
- Previous surgery of the upper gastrointestinal tract
- Achalasia
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Anahi Perlas, MD, (416) 603-5800 ext. 5118, anahi.perlas@uhn.ca
Didem Bozak, (416) 603-5800 ext. 2016, didem.bozak@uhnresearch.ca
About this study
Official title: Do Standard Preoperative Fasting Instructions Ensure an Empty Stomach in Diabetic Patients? A Prospective Comparative Cohort Study
This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures.
Read the detailed description
Any surgical procedure carries an inherent risk of pulmonary aspiration. Food or liquid from the stomach might be forced back up the throat from where it could enter the lungs (aspiration) resulting in serious complications prolonging the hospital stay or in extreme circumstances death.
The risk of this is slightly higher in diabetics when compared to non-diabetics as the emptying of contents from the stomach is slightly delayed. This is why people going for surgery are asked not to eat for a specific time before their surgery. 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.
This study aims to evaluate the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures. The investigators also aim to find an association between the type and duration of diabetes mellitus with residual gastric volume. Episodes of intra-operative regurgitation, vomiting or aspiration will also be documented.
- Keywords
- Diabetes, Diabetes Mellitus, Gastric Ultrasound, Preoperative fasting, Empty Stomach, Gastric Diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Group | A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. | |
| Non-Diabetic Group | A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Gastric Contents
A "full stomach" is defined as one containing a) solid or thick fluid content or b) > 1.5 mL/kg of clear fluid.
There are 4 categories regarding gastric contents:
- Empty Stomach
- Grade 1 Clear Fluid (fluid only observed in supine or right lateral decubitus position)
- Grade 2 Clear Fluid (fluid only observed in both supine and right lateral decubitus position)
- Solid
Measured: Less than two hour prior to surgery
Secondary outcomes (5)
Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients
Characterize the distribution of baseline gastric volume in fasted diabetic and non-diabetic patients
Measured: Less than two hour prior to surgery
Define the upper limit of normal fasting gastric volume defined as the 95th percentile
Define the upper limit of normal fasting gastric volume defined as the 95th percentile
Measured: Less than two hour prior to surgery
Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients
To study the association between type of diabetes mellitus (I or II), duration and degree of glycemic control with baseline gastric fluid volume
Measured: Less than two hour prior to surgery
Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.
To study the relationship between gastric volume in diabetic patients in relation with which medication and/or treatment they use to manage their diabetes. Examples of medication or treatment include; pharmaceutical hypoglycemics, insulin, or diet controlled.
Measured: Less than two hour prior to surgery
Episodes of intra-operative regurgitation, vomiting or aspiration
Episodes of intra-operative regurgitation, vomiting or aspiration
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888951
- Sponsor's protocol ID
- 15-8808-AE
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: It is undecided at this time whether data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Standard Preoperative Fasting Instructions Ensure an Empty Stomach in Diabetic Patients? A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT02888951
- Acronym / sponsor ID
- 15-8808-AE
- Keywords
- Diabetes, Diabetes Mellitus, Gastric Ultrasound, Preoperative fasting, Empty Stomach, Gastric Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 5 Sep 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.
This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures.
Detailed description
Any surgical procedure carries an inherent risk of pulmonary aspiration. Food or liquid from the stomach might be forced back up the throat from where it could enter the lungs (aspiration) resulting in serious complications prolonging the hospital stay or in extreme circumstances death.
The risk of this is slightly higher in diabetics when compared to non-diabetics as the emptying of contents from the stomach is slightly delayed. This is why people going for surgery are asked not to eat for a specific time before their surgery. 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.
This study aims to evaluate the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures. The investigators also aim to find an association between the type and duration of diabetes mellitus with residual gastric volume. Episodes of intra-operative regurgitation, vomiting or aspiration will also be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Group | – | –A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. |
| Non-Diabetic Group | – | –A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be patients whom are scheduled to undergo elective surgical procedures requiring preoperative fasting period of at least 8 hours. 240 patients will be recruited in total. One cohort consisting 120 patients will be diabetic (type 1 or 2). The other cohort consisting of 120 patients will be non-diabetic.
Key inclusion criteria (3 listed)
- Patients scheduled for elective surgery aged 18 to 85 years
- American Society of Anesthesia physical status classification I to III
- Body mass index < 40 kg/ cm2.
Key exclusion criteria (3 listed)
- Pregnancy (currently or within the past 3 months)
- Previous surgery of the upper gastrointestinal tract
- Achalasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of Gastric Contents
Time frame: Less than two hour prior to surgery
A "full stomach" is defined as one containing a) solid or thick fluid content or b) > 1.5 mL/kg of clear fluid. There are 4 categories regarding gastric contents: 1. Empty Stomach 2. Grade 1 Clear Fluid (fluid only observed in supine or right lateral decubitus position) 3. Grade 2 Clear Fluid (fluid only observed in both supine and right lateral decubitus position) 4. Solid
5 secondary outcomes
Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients
Time frame: Less than two hour prior to surgery
Define the upper limit of normal fasting gastric volume defined as the 95th percentile
Time frame: Less than two hour prior to surgery
Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients
Time frame: Less than two hour prior to surgery
Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.
Time frame: Less than two hour prior to surgery
Episodes of intra-operative regurgitation, vomiting or aspiration
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided. It is undecided at this time whether data will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anahi Perlas, MD ((416) 603-5800 ext. 5118, anahi.perlas@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Gastric Contents (time frame: Less than two hour prior to surgery). 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 18 Jan 2020.