An observational study in Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction and Coronary Artery Disease, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Istanbul University - Cerrahpasa · Observational
Fasting before surgery does not always ensure that the stomach is empty. Residual gastric contents may be relevant to the risk of stomach contents entering the lungs during anaesthesia.
This multicentre prospective observational study will enrol 240 adults scheduled for elective isolated coronary artery bypass grafting at two hospitals in Türkiye. Gastric ultrasound will be performed before any sedative or anaesthetic medication is administered. The study will determine the proportion of patients with high-risk gastric contents despite routine preoperative fasting.
High-risk gastric contents will be defined as any solid or thick contents, or an estimated clear fluid volume greater than 1.5 mL/kg. Associations with patient characteristics, medical conditions, medication use and fasting duration will also be examined.
The anaesthetist's management plan will be recorded before the ultrasound findings are known. After the findings are communicated, any changes in surgical timing, anaesthetic induction, airway management or aspiration precautions will be documented. Fasting practices will not be modified for research purposes, and all clinical decisions will remain with the attending anaesthetist.
An additional secondary objective is to identify preoperative factors associated with high-risk gastric contents detected by gastric ultrasound. High-risk gastric contents will be defined as any solid or thick gastric contents or an estimated clear fluid volume greater than 1.5 mL/kg, consistent with the primary outcome definition. Candidate variables will include age, sex, body mass index, diabetes mellitus and its duration, insulin use, chronic kidney disease, gastro-oesophageal reflux disease, hypothyroidism, preoperative laboratory values and medication use specified in the study protocol, and actual solid food and clear fluid fasting durations. These data will be obtained from participant interviews and preoperative medical records. Associations will be evaluated using logistic regression and reported as odds ratios with 95% confidence intervals, where estimable. Multivariable analysis will be performed if the number of participants with high-risk gastric contents permits, with the number of included variables restricted to reduce the risk of model overfitting.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 240 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
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Adults aged 18 years or older scheduled for elective isolated coronary artery bypass grafting at Istanbul University-Cerrahpasa Institute of Cardiology and Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Türkiye. Patients prepared according to routine institutional preoperative fasting practices will be assessed consecutively during the recruitment period. Eligible patients who provide written informed consent will be enrolled.
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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.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Adults aged 18 years or older scheduled for elective isolated coronary artery bypass grafting at two participating centres, prepared according to routine institutional fasting practices. Participants will undergo preoperative gastric ultrasound before receiving any sedative or anaesthetic medication. Gastric contents and the anaesthetic management plans before and after disclosure of ultrasound findings will be recorded prospectively. All clinical decisions will remain at the discretion of the attending anaesthetist.
Proportion of Participants With High-Risk Gastric Contents on Preoperative Gastric Ultrasound
Percentage of participants with high-risk gastric contents, defined as any solid or thick gastric contents or an estimated clear fluid volume greater than 1.5 mL/kg. Clear fluid volume will be estimated using the Perlas model based on the mean of three gastric antral cross-sectional area measurements obtained in the right lateral decubitus position. An empty stomach or clear fluid volume of 1.5 mL/kg or less without solid or thick contents will be classified as low risk. Perlas grade 2 alone will not define high-risk gastric contents.
Time frame: During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.
Proportion of Participants With a Change in Planned Anaesthetic Management or Surgical Timing After Disclosure of Gastric Ultrasound Findings
Percentage of participants with a change in surgical timing, planned anaesthetic induction technique, planned intubation approach or device, or planned aspiration precautions. The management plan recorded before gastric ultrasound will be compared with the decision and revised plan recorded immediately after the findings are disclosed to the attending anaesthetist.
Time frame: On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.
Proportion of Participants With a Management Change Directly Attributed to Gastric Ultrasound Findings
Percentage of all evaluated participants whose attending anaesthetist identifies the gastric ultrasound findings as the direct reason for a change in planned anaesthetic management or surgical timing. The type of change and the clinician-reported reason will be recorded.
Time frame: Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.
Plan to share: No — There is currently no plan to share individual participant data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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