Health TrialsbyHealthPanel

Gastric Ultrasound in Elective Surgical Diabetic Patients

ConditionsGastric UltrasoundElective SurgeryDiabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University

About this trial

The aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Both sexes.

Undergoing elective surgery.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Gastric ultrasound

    Device

    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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Group I - Diabetic1 intervention
Group B: Group II - Non-diabetic1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Just before surgery

Secondary outcomes

1

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)

Time frame
Just before surgery
2

Gastric volume/weight

Gastric volume/weight will be recorded.

Time frame
Just before surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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