An observational study in Pulmonary Aspiration and Gastric Content Aspiration, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Beni-Suef University · Observational
The aim of the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section.
Fasting is a mandatory requirement prior to elective anesthesia and is intended to reduce gastric fluid volume and the risk of aspiration of gastric contents and subsequent organ injury. Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality and its severity depends upon the gastric volume and nature of the aspirate.
A high-risk stomach refers to a gastric volume associated with an increased risk of pulmonary aspiration and is defined in most published literature as the presence of any solid or liquid content >1.5 mL/kg Pregnant women have been considered to be at particular risk of aspiration syndromes as a consequence of physiological changes during pregnancy which lead to relaxation of lower oesophageal sphincter and mechanical upward displacement of the stomach by the enlarged uterus.
European Society of Anaesthesiology (ESA) recommends fasting for ≥2 hours after clear liquids and 6 hours after light meals before elective surgery, including in pregnant patients. In contrast, the American Society of Anesthesiology guidelines specifically exclude pregnant women and the Society for Obstetric Anesthesia and Perinatology taskforce recommended a fasting period of 6-8 hours, depending on the nature of food ingested.
Diabetic patients can present with diabetic gastropathy, an autonomic neuropathy associated with delayed gastric emptying in the absence of gastric outlet obstruction tend, predisposing them to increased risk of aspiration as compared to non-diabetic patients.
To date, standard fasting guidelines for people with diabetes are still up for debate.. European Society of Anaesthesiology (ESA) 2011 Fasting guidelines state that diabetic patients can follow the same guidelines as healthy adults, While American Society of Anesthesiologists (ASA) in 2017 fasting guidelines mentioned that the standard eight hours fasting may not apply or may need to be modified for patients with coexisting diseases or conditions that can affect gastric emptying or fluid volume.
With the advent of portable ultrasound machines, performing point-of-care ultrasound has become relatively easy and feasible. Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment. It can identify the nature and the volume of the gastric content, i.e., empty, clear fluid and solid and when clear fluid is present, its volume can be quantified.
In this study, we will analyse the stomach contents of Non-labouring term pregnant women after six and eight hours of fasting, using previously described qualitative and quantitative ultrasonographic assessments.
27 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 11 observational studies indexed under Respiratory Aspiration of Gastric Contents.
Browse Respiratory Aspiration of Gastric Contents studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
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Eligible 140 patients are aged from 18-40 years, with an American Society of Anaesthesiologists (ASA) physical status of II-III, and are scheduled to undergo elective caesarean section.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes
Device: Gastric ultrasonography
Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes
Device: Gastric ultrasonography
Women will be requested to fast 2 hours for clear drinks, 6 hours for a light meal, and 8 hours for a meal high in fried or fatty content prior to their next antenatal clinic visit. On the day of assessment, fasting and dietary compliance will be confirmed individually with each woman and Gastric ultrasonography will be performed after sex and eight hours of fasting food. Women will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by a semi-recumbent (45 degrees head up) right lateral position (RLP). In both positions the gastric antrum will be identified in the sagittal plane with its internal anatomical landmarks identified, i.e. the left lobe of the liver anteriorly and the abdominal aorta posteriorly.
mean antral cross-sectional area of stomach
mean antral cross-sectional area of stomach after 8 h of fasting in term pregnant diabetic and non-diabetic women undergoing elective caesarean section.
Time frame: 8 hours of fasting
the mean antral cross-sectional area of stomach
mean antral cross-sectional area of stomach after 6 h of fasting presence of solid food contents in the gastric antrum,
Time frame: 6 hours of fasting
gastric antral grade
The qualitative assessment of the gastric contents will be also done for presence of any clear fluid or solid food particles and a gastric antral grade, as described by Perlas et al. was designated based on the presence of fluid as follows: Grade 0 = absence of fluid in both supine and RLP; Grade 1 = fluid in RLP only; Grade 2 = fluid in both supine and RLPs
Time frame: 6 and 8 hours of fasting
Started Sep 2024 (actual). Primary completion is estimated for Sep 2025, 12 months after the start.
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