Aspiration Clinical Trial
Official title:
Lecturer of Anesthesia
Pulmonary aspiration of gastric contents is uncommon in the elective, surgical populations, but highly prevalent in trauma patients who requires emergency surgery as trauma impair gastric motility and emptying.1 Presence of residual gastric volume at the time of anesthetic induction is an important risk of aspiration pneumonitis.2 Routine use of non-invasive bedside ultrasound gives information about the volume and nature of gastric volume. Determination of gastric content volume preoperatively will help the anesthetist in the assessment of pulmonary aspiration risk 3, 4 Ultrasongraphic measurment of antral CSA (cross sectional area) can diagnose risk stomach during the preoperative period defined by a gastric volume at risk of pulmonary aspiration (ie presence of Solid particles and/or gastric volume >1.5 ml/kg)5 The aim of our study is to allow routine use of point of care ultrasound (pocus) of gastric contents in order to inform an assessment of aspiration risk and guide anesthetic mangment
A prospective randomized study will be conducted in Ain Shams University Hospital-Emergency
Department. Institutional Research Ethics Committee approval will be obtained and written
informed consent will be obtained from all participants before enrollment. The study included
forty five polytrauma patients (18-65 years old of both sexes) admitted for emergency
surgery.
On admission, ABC protocol will be applied, (GCS) Glasgow coma scale assessment, complete
laboratory investigations and radiology and complete clinical examination with assessment of
fasting hours.
Exclusion criteria are patients with obesity (BMI> 35kg/m2), pregnancy, a history of upper
gastrointestinal diseases including gastroesophageal reflux disease, hiatus hernia,
gastroeosphgeal cancer or upper GIT surgery.
A curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be
used. All patient will be first scanned in the supine position, followed by the right lateral
decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in
the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver
anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical
reference points.
Fig. (1): Sagittal/parasgittal scanning plane for gastric assessment
Fig. (2) A Sagittal sonogram of the gastric antrum. A = antrum; L = liver; P = pancreas; SMA
= superior mesenteric artery; Ao = aorta. B Schematic representation of sagittal sonoanatomy.
A = antrum; L = liver; P = pancreas; SMA = superior mesenteric artery; Ao = aorta
The "empty" antrum appeared collapsed and "flat" with the anterior and posterior walls very
close to each other or round to ovoid in shape resembling a "bull's eye" target.
The antrum appeared distended with a round shape when filled with a clear fluid. Multiple gas
"bubbles" appeared as punctuate hyperechoic areas within the hypoechoic fluid, mimicking a
"starry night" appearance.
The antrum appeared distended with a contents of mixed echogenicity when filled with a solid
contents give the antrum "frosted glass" appearance.
When the stomach contains clear fluid, a volume assessment can help differentiate a
negligible volume consistent with baseline secretions vs a higher than baseline volume. So,
the antral cross sectional area (CSA) was calculated after measuring the two dimensions of
the antrum (D1 an D2) according to the following equation: π (D1 x D2)/4 and the volume of
clear fluid was calculated using a cross- sectional area CSA of the antrum measured in the
RLD and a previously published mathematical model: volume (ml)= 27.0+(14.3 x Right - lat
(CSA) - (1.25 x age). This equation accurately predicts gastric volume up to 500 ml.
Nasogastric ryle will be inserted (if there is no contraindication) to confirm gastric
ultrasound volume calculation.
Additionally, the antrum as classified according to a 3-point grading system (perlas grade
0-2) that is based on the absence or presence of clear fluid in the supine and RLD positions.
Grade 0 refers to the absence of gastric content in the antrum in both supine and RLD
positions. Grade 1 refers to antral clear fluid that is appreciable only in the RLD. Grade 2
refers to clear fluid that is documented in both the supine and RLD positions.
Fig.(3): flow chart for interpretation of findings and medical decision- making based on
gastric point of care ultrasound findings. Used with permission from gastric ultrasound. Org
The low risk result will suggest that the risk of aspiration is low and it may be safe to
proceed with surgery with a slowly titrated induction of anesthesia as dictated by the
patient's cardiac condition using laryngeal mask or E.T.T.
The high risk result will suggest that the risk of aspiration is high, and this finding would
support: 1, postponing surgrery, till completion of fasting hours 2 loco-regional anesthesia;
neuraxial anesthesia, and 3, general anesthesia with rapid sequence induction, up to awake
fibro-optic intubation.
We will record the incidence of change in anesthetic technique and change in timing of
surgical procedure (as a primary outcome) and incidence of perioperative aspiration (as a
secondary outcome) when we use gastric ultrasound preoperatively in these patients.
Sample size:
Using medical program setting alpha error at 5% & power at 90% we calculated our sample size
based on the result of (sabry et al., 2018) which showed very good correlation between
gastric volume using ultrasound and volume of aspirated gastric content with an assumed
(r=0.5). Based on this the needed sample is 45 cases taken in account 10% drop out rate.
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