An observational study in Aspiration Pneumonia, sponsored by Fayoum University Hospital. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Fayoum University Hospital · Observational
Gastric emptying is a major risk factor for aspiration of gastric contents.Aspiration into the lungs represents a fatal complication that can occur during anesthesia.
Not only gastric emptying importance to anesthetists is related to aspiration but also it is important to determine the systemic availability of substances given through the mouth. Delayed gastric emptying represents a major danger as it causes nausea and vomiting and prevents a return to oral feeding. Lastly it may cause morbidity and mortality.
Both humoral and neural influences have their impact on emptying. Volume and composition of gastric food act as major determinants for the rate of gastric emptying. The effect of body weight on gastric emptying are inconsistent.
ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia.
These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying.
Ultrasound can be used perioperatively to asses gastric content and volume at bedside.
The objective of the current study is to evaluate gastric residual volume in obese patients versus healthy controls scheduled for elective surgery, using gastric ultrasound.
This prospective observational study was performed on 100 patients undergoing elective surgery from July 2019 to June 2020 at Fayoum University hospital after approval of the local institutional ethical committee (M420). A detailed informed consent was signed by the eligible participants before enrollment.
Our study adheres to the CONSORT guidelines. The study was conducted on 100 Patients were assigned to one of two groups of (50) patients in each group. Group obese ASA II from( 30-40) BMI, ASA III above 40 BMI without other comorbidities and group non obese ASA I control.Obese patients whose BMI >30 and healthy patients whose BMI = 18-24.9 who was scheduled for an elective surgery were included in this trial. All patients were enrolled in the study aged above >20 y. This study included patients scheduled for elective surgery after 8-hour overnight fast after a light meal.
Ultrasound scanning:
Focused gastric ultrasound by was performed by a trained physician in semi-sitting position then right lateral position using low frequency (2-5MHz) mindray curved transducer and mindray DP-20 ultrasound system. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark.
The antrum was considered to be empty if flat with juxtaposed anterior and posterior walls, fluid-containing if distended with thin walls and hypoechoic contents, solid -containing if distended with a content with mixed echogenicity according to antral shape and contents .
The antral cross sectional area (CSA) was measured using the two antral dimensions, craniocaudal (D1) and anteroposterior (D2) dimensions, according to the following equation: π [D1×D2]/4 provided that π = 22/7.
The gastric residual volume was calculated according to patient position as follows:
Bouvet and colleagues equation for semi-sitting position: gastric residual volume (ml) =215 + 57 log CSA (mm2) - 0.78 age (year) - 0.16 height (cm) - 0.25 weight (kg) - 0.80 ASA.
Perlas and colleagues equation for right lateral position: gastric residual volume (ml) = 27.0 + 14.6 × right-lateral CSA - 1.28 × age.
Using the classification of Ven de Putte and perlas, the study could asses the risk of aspiration as follows: (a) low risk of aspiration: patients with empty antrum and patients with gastric residual volume less than 1.5 ml/kg.(b) high risk of aspiration: patients with solid contents and patients with gastric residual volume more than 1.5 ml/kg.
Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
Statistical Analysis The collected data were organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). Numerical variables were not normally distributed and were presented as median and interquartile range (IQR); Mann-Whitney U test was used as a test of significant. Qualitative data were presented as numbers and percentages, and the chi-squared test was used to determine significance. A two-sided P-value of \<0.05 was considered statistically significant.
Sample size Sample size calculated using G-Power© software version 3.1.7 results with effect size (0.57), two sided (two tails) type I error 0.05 and power of 80%, each group should include at least (50) Subjects. the authors expected no dropout rates or missing data.
64 studies on the registry are indexed under Pneumonia, Aspiration; 12 are open to participants now.
This study's enrollment of 100 is close to the median of 91 across 22 observational studies indexed under Pneumonia, Aspiration.
Browse Pneumonia, Aspiration studies →Fayoum University Hospital is the lead sponsor of 73 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This prospective observational study will be performed on 100 patients undergoing elective surgery in fayoum university
Exclusion Criteria:
patients with body mass index =18-24.9 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area in semi-sitting and right lateral positions
Device: gastric ultrasound · Procedure: nasogastric tube insertion
patients with body mass index \>30 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area semi-sitting and right lateral positions
Device: gastric ultrasound · Procedure: nasogastric tube insertion
Focused gastric ultrasound was performed in semi-sitting position then right lateral position mindray curved transducer for examination of abdomen with low frequency (2-5 MHz) by a trained physician. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark
Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
Also known as: Ryle tube
measurement of gastric residual volume in semi-sitting position
in cubic centimetre
Time frame: 5 minutes preoperatively
measurement of gastric residual volume in right lateral position.
in cubic centimetre
Time frame: 5 minutes preoperatively
Antral cross sectional area in semi-sitting position
in millimetre square
Time frame: 5 minutes preoperatively
Antral cross sectional area in right lateral position
in millimetre square
Time frame: 5 minutes preoperatively
volume of fluid aspirated from nasogastric tube
in cubic centimetre
Time frame: 1 minute after induction of anesthesia
grade of aspiration risk
less (low risk) or more (high risk) 1.5 millilitre/kilogram
Time frame: 5 minutes preoperatively
Grading for assessment of antrum of the stomach
: 3 points as follows: grade 0: empty antrum, grade 1: minimal fluid in right lateral position only, grade 2: distention of antrum in both right lateral and semi-sitting position
Time frame: 5 minutes preoperatively
Age
in years
Time frame: 1 hour preoperatively
Weight
in kilograms
Time frame: 1 hour preoperatively
Body mass index
in kilograms/ square metre
Time frame: 1 hour preoperatively
Height
in centimetre
Time frame: 1 hour preoperatively
Plan to share: Undecided
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fayoum University Hospital