Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04668651 |
| Other study ID # |
20-PP-17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 12, 2021 |
| Est. completion date |
April 5, 2021 |
Study information
| Verified date |
November 2023 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Gastric aspiration represents the third cause of perioperative death in France. In scheduled
surgery, it can be prevented by preoperative fasting. The French and American guidelines
recommend a fasting of 2 hours for clear liquids and 6 hours for solid food. However, these
durations could be too short in case of delayed gastric emptying due to medications of
diabetes for example. This latter condition has an increasing incidence. Numerous
complications are related to chronic hyperglycemia including delayed gastric emptying also
known as gastroparesis. Around one third of diabetic patients presents this complication.
Gastric ultrasound represents a non-invasive method to explore the stomach. It allows the
qualitative and quantitative evaluations of gastric content.
As diabetic patients present a risk of non-empty stomach despite fasting,investigators
decided to conduct a prospective observational study compare the appearance of the stomach
assessed by ultrasonography between diabetic and non-diabetic patients before scheduled
surgery
Description:
Gastric aspiration represents the third cause of perioperative death in France. The
physiopathology of this complication is multifactorial, implying among other things the lack
of respect for the rules of preoperative fasting, especially during emergency operations.
Indeed, the presence of food content in the stomach, combined with the decrease in the
pressure of the lower sphincter of the esophagus and the protection of the upper airways
during the induction of general anesthesia, is accompanied by a significant increase in the
risk of regurgitation and inhalation of gastric contents.
There are more than 3 million diabetic patients in France, with an increase in prevalence of
more than 5% per year. The main digestive disorder linked to autonomic neuropathy in the
diabetic subject is represented by gastroparesis, characterized by a delay in gastric
emptying without mechanical impediment, associated with signs of abnormal gastric motility.
Gastroparesis results from an impairment of the neurovegetative regulation of the stomach
related to exposure to prolonged hyperglycemia. It is estimated that approximately 1/3 of
diabetics are affected.
Ultrasound measurement of the antral section area was originally described for the evaluation
and study of gastric emptying in obstetrics and medicine. Several studies have shown the
interest of this measurement for the evaluation of gastric content and volume in the
preoperative period. The antral ultrasound makes it possible to discriminate a "full" stomach
from an "empty" stomach with excellent performance. Thus, investigators have at our disposal
a simple and non-invasive tool to evaluate in real time the state of gastric vacuity in
patients in the operating room.
In practice, ultrasound measurement of the antral section area is performed using an
ultrasound scanner equipped with a 2-5 MHz frequency probe. The diameters (longitudinal D1
and anteroposterior D2) of the antrum are measured in the sagittal plane passing through the
abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area
is given by the formula: antral area = π x D1 x D2 / 4. This ultrasound measurement of the
antral cross-sectional area is commonly performed in the operating room and is recommended in
some anesthesia reference books. Several mathematical models have been constructed, in adults
and children, to calculate the volume of gastric contents based on this measurement of anal
area, with satisfactory accuracy (R² = 0.72 to 0.86). Gastric ultrasound is easily performed
at the patient's bedside, before general or local anesthesia, and its use has recently been
described to study gastric emptying.
Investigators would like to evaluate the gastric content in diabetics in the perioperative
period.
