Evaluation of ASA Fasting Recommendations in Diabetic Patientsgastric USNCT03184532
Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients
An observational study of Evaluation of ASA Fasting Recommendations in Diabetic Patients, run by Healthpoint Hospital.
Trial summary
To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluation of ASA Fasting Recommendations in Diabetic Patients
- What is being tested?
- ultrasound
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective orthopedic procedures.
Who may be able to join
- Patients scheduled for elective orthopedic procedures.
Who cannot join
- Patients with BMI > 35 kg.m-2, age <18y, ASA physical state >II, fasting more than 6hs, or with gastric diseases will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting. The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
ultrasound examination of pyloric antrum
| Study group | Role | What they receive |
|---|---|---|
| D | diabetic patients Receives: Diagnostic Test: ultrasound | |
| ND | non-diabetic patients Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric volume
Measured: bedside test 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion15 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of ASA Fasting Recommendations in Diabetic PatientsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthpoint Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Elahl, Healthpoint Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184532
- Sponsor's protocol ID
- rec003
- Acronym
- gastric US
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients
- ClinicalTrials.gov ID
- NCT03184532
- Acronym / sponsor ID
- gastric US / rec003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Healthpoint HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 15 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 12 Jun 2017 (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.
To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting. The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D | – | Diagnostic Test: ultrasounddiabetic patients |
| ND | – | Diagnostic Test: ultrasoundnon-diabetic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective orthopedic procedures.
Key inclusion criteria (1 listed)
- Patients scheduled for elective orthopedic procedures.
Key exclusion criteria (1 listed)
- Patients with BMI > 35 kg.m-2, age <18y, ASA physical state >II, fasting more than 6hs, or with gastric diseases will be excluded
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 examination of pyloric antrum | Diagnostic test | D, ND |
Primary outcome
gastric volume
Time frame: bedside test 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of ASA Fasting Recommendations in Diabetic Patients, run by Healthpoint Hospital.
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 1 inclusion and 1 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 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Sayed Elahl, MD (00971501257051, m.elahl@healthpoint.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric volume (time frame: bedside test 5 minutes). 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 12 Jun 2017.