Gastric Ultrasound in Diabetic Patients

Diabetes Clinical Trial

Official title:

Preoperative Evaluation of Gastric Contents in Diabetic Patients With Gastric Ultrasound

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06195488
• Other study ID #: 2022/17-1
• Status: Active, not recruiting
• Start date: October 15, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery.

The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality.

Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death.

The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration.

Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting.

Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 1, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed consent obtained 40-65 BMI<40 ASA I-III Fasting for at least 8 hours Elective surgery

Exclusion Criteria:

• Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI =40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis

Related Conditions & MeSH terms

• Diabetes
• Gastric Emptying
• Ultrasound

Intervention

Procedure:
• Gastric ultrasound
performing gastric ultrasound to determine gastric contents

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine stomach fullness	To evaluate residual gastric volume in diabetic patients fasting for elective surgery	baseline (before intubation)
Secondary	Incidence of risk factors	Investigating risk factors for a full stomach in diabetic patients	during surgery