Gastric UltrasoundNCT06600035
Gastric Ultrasound in Elective Surgical Diabetic Patients
An observational study of Gastric Ultrasound and Elective Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ultrasound, Elective Surgery, Diabetes Mellitus
- What is being tested?
- Gastric ultrasound
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2024to 1 Apr 2025
- 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: This case-control study will be carried out on 130 cases, aged ≥ 18 years, undergoing elective surgery at Tanta University Hospitals after approval from the institutional ethical committee.
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Undergoing elective surgery.
Who cannot join
- American Society of Anesthesiology (ASA) physical status >III.
- Body mass index (BMI) outside the range of 18.5-40 Kg/m2.
- History of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen.
- Abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month).
- Taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids).
- Hypothyroidism.
- Current smoking history.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
Mohammad H Alqassas, MD
About this study
The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.
Read the detailed description
Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. The overall incidence of gastric content aspiration ranges between <0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. Mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration.
Consequently, American Society of Anesthesiologists (ASA) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. However, there are still many situations where the ASA fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus.
Ultrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. As diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (GV) of diabetic patients and see if it is more than the recommended safe limit.
As a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management.
- Conditions
- Gastric Ultrasound, Elective Surgery, Diabetes Mellitus
- Being tested
- Gastric ultrasound
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDevice
A curved array, low-frequency (2-5 MHz) transducer providing a scan depth up to 30 cm will be used. Patients will be scanned in the supine position followed by right lateral decubitus (RLD) position. The sonographic appearance of the gastric antrum will be classified as Grade 0,1 or 2, signifying empty antrum, fluid detected in RLD position only and antral fluid in both supine and RLD positions, respectively, based on the appearance in both the positions. Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:CSA = (AP × CC × π)/4
| Study group | Role | What they receive |
|---|---|---|
| Group I - Diabetic | Diabetic patients Receives: Device: Gastric ultrasound | |
| Group II - Non-diabetic | Non-diabetic patients Receives: Device: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral cross-sectional area (CSA)
Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:
CSA = (AP × CC × π)/4
Measured: Just before surgery
Secondary outcomes (2)
Gastric volume
The gastric volume will be calculated using the previously validated formula:
GVe (gastric volume in ml) = 27.0 + [14.6 × right - lateral CSA (cm2)] - (1.28 × age)
Measured: Just before surgery
Gastric volume/weight
Gastric volume/weight will be recorded.
Measured: Just before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600035
- Sponsor's protocol ID
- 36264PR801/8/24
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound in Elective Surgical Diabetic Patients
- ClinicalTrials.gov ID
- NCT06600035
- Acronym / sponsor ID
- 36264PR801/8/24
- Conditions
- Gastric Ultrasound, Elective Surgery, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.
Detailed description
Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. The overall incidence of gastric content aspiration ranges between <0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. Mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration.
Consequently, American Society of Anesthesiologists (ASA) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. However, there are still many situations where the ASA fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus.
Ultrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. As diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (GV) of diabetic patients and see if it is more than the recommended safe limit.
As a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Diabetic | – | Device: Gastric ultrasoundDiabetic patients |
| Group II - Non-diabetic | – | Device: Gastric ultrasoundNon-diabetic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study will be carried out on 130 cases, aged ≥ 18 years, undergoing elective surgery at Tanta University Hospitals after approval from the institutional ethical committee.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Undergoing elective surgery.
Key exclusion criteria (8 listed)
- American Society of Anesthesiology (ASA) physical status >III.
- Body mass index (BMI) outside the range of 18.5-40 Kg/m2.
- History of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen.
- Abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month).
- Taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids).
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 |
|---|---|---|
| Gastric ultrasoundA curved array, low-frequency (2-5 MHz) transducer providing a scan depth up to 30 cm will be used. Patients will be scanned in the supine position followed by right lateral decubitus (RLD) position. The sonographic appearance of the gastric antrum will be classified as Grade 0,1 or 2, signifying empty antrum, fluid detected in RLD position only and antral fluid in both supine and RLD positions, respectively, based on the appearance in both the positions. Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse:CSA = (AP × CC × π)/4 | Device | Group I - Diabetic, Group II - Non-diabetic |
Primary outcome
Antral cross-sectional area (CSA)
Time frame: Just before surgery
Cross-sectional area (CSA) will be calculated by using two perpendicular diameters-anteroposterior (AP) and craniocaudal (CC) and the formula for area of an ellipse: CSA = (AP × CC × π)/4
2 secondary outcomes
Gastric volume
Time frame: Just before surgery
Gastric volume/weight
Time frame: Just before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Gastric Ultrasound and Elective Surgery, run by Tanta University at 1 site in Egypt.
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 8 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 19 Sep 2024. 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 Egypt. 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 Mohammed S ElSharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral cross-sectional area (CSA) (time frame: Just before 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 19 Sep 2024.