Aspiration PneumoniaNCT04181814
Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients
An observational study of Aspiration Pneumonia and Gastric Volume, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia, Gastric Volume
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2019to 2 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients undergoing elective surgery and firmly following ASA fasting guidelines.
Who may be able to join
- Ages >18 years old
- Diabetes (I or II)
- Following American Society of Anesthesiologists (ASA) fasting guidelines before surgery
- Undergoing general anesthesia
Who cannot join
- Pregnant
- Gastric Intestinal Tract (GIT) diseases or surgeries affect gastric emptying
- Diagnosed with liver dysfunction or renal insufficiency
- Patients who are unable to cooperate or understand the process
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310000
About this study
Official title: Bedside Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients Following ASA Fasting Guidelines
ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.
Read the detailed description
ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance.
Using gastric ultrasound measure gastric antrum cross-sectional area to determine whether patients are empty stomach, help anesthesiologists in preoperative evaluation of diabetic patients with the risk of aspiration, so as to guide the anesthesiologist take effective interventions, this prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.
- Conditions
- Aspiration Pneumonia, Gastric Volume
- Being tested
- Ultrasound
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Use ultrasound to assess gastric contents in diabetic patients before anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Diagnosed as diabetes Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric contents
using ultrasound to evaluate antral cross-sectional area
Measured: before anesthesia
Risk factors
by analysisng full stomach of patients to find risk factors
Measured: before anesthesia
Secondary outcomes (1)
Perlas grading scale
This is a 3-point grading system (grades 0, 1, and 2) based exclusively on qualitative sonographic assessment of the gastric antrum.If a patient's antrum appears empty in both supine and right lateral positions (grade 0), it is likely truly empty. If it appears only mildly distended in the right lateral decubitus position, but not in the supine position (grade 1), the patient likely has a very small volume of gastric fluid within the limits of what is known to be "safe". An antrum that is distended in both supine and right lateral decubitus positions (grade 2) denotes a gastric fluid volume beyond the limits of what is considered safe.
Measured: before anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start15 Nov 2019
- Primary completion20 Jan 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Study chair, The Second Affiliated Hospital of Zhejiang University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181814
- Sponsor's protocol ID
- 2019-319
- Status last verified
- Nov 2019
- First submitted
- 27 Nov 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients Following ASA Fasting Guidelines
- ClinicalTrials.gov ID
- NCT04181814
- Acronym / sponsor ID
- 2019-319
- Conditions
- Aspiration Pneumonia, Gastric Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 29 Nov 2019 (actual)
- 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.
ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.
Detailed description
ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance.
Using gastric ultrasound measure gastric antrum cross-sectional area to determine whether patients are empty stomach, help anesthesiologists in preoperative evaluation of diabetic patients with the risk of aspiration, so as to guide the anesthesiologist take effective interventions, this prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Device: UltrasoundDiagnosed as diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients undergoing elective surgery and firmly following ASA fasting guidelines.
Key inclusion criteria (4 listed)
- Ages >18 years old
- Diabetes (I or II)
- Following American Society of Anesthesiologists (ASA) fasting guidelines before surgery
- Undergoing general anesthesia
Key exclusion criteria (4 listed)
- Pregnant
- Gastric Intestinal Tract (GIT) diseases or surgeries affect gastric emptying
- Diagnosed with liver dysfunction or renal insufficiency
- Patients who are unable to cooperate or understand the process
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 |
|---|---|---|
| UltrasoundUse ultrasound to assess gastric contents in diabetic patients before anesthesia | Device | Diabetic patients |
Primary outcome
Gastric contents
Time frame: before anesthesia
using ultrasound to evaluate antral cross-sectional area
Risk factors
Time frame: before anesthesia
by analysisng full stomach of patients to find risk factors
1 secondary outcome
Perlas grading scale
Time frame: before anesthesia
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 6 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Min Yan, Doctor study chair
The Second Affiliated Hospital of Zhejiang University Medical College
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 Aspiration Pneumonia and Gastric Volume, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 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 6 Mar 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 China. 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 contents (time frame: before anesthesia). 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 6 Mar 2020.