Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Gastric Ultrasound Assessment and Anaesthetic Management in Adults Undergoing Elective Isolated Coronary Artery Bypass Grafting: A Multicentre Prospective Observational Study
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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gozde Altun
- Telefonnummer: +90 554 429 03 33
- E-mail: gozde.altun@iuc.edu.tr
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Istanbul University-Cerrahpasa Institute of Cardiology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- Age 18 years or older.
- Scheduled for elective isolated coronary artery bypass grafting.
- Prepared according to routine institutional preoperative fasting practices.
- Provision of written informed consent.
Exclusion Criteria:
- Scheduled for emergency or urgent coronary artery bypass grafting.
- Planned concomitant cardiac surgical procedure.
- Body mass index of 40 kg/m² or greater.
- Previous gastric or oesophageal surgery resulting in substantially altered gastric anatomy.
- Gastric outlet obstruction or known mechanical gastrointestinal obstruction.
- Inability to perform gastric ultrasound or obtain reliable measurements because of technically inadequate imaging.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
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Patients Scheduled for Elective Isolated CABG
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of Participants With High-Risk Gastric Contents on Preoperative Gastric Ultrasound
Tidsramme: During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.
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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. |
During the preoperative gastric ultrasound examination, before administration of any sedative or anaesthetic medication.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of Participants With a Change in Planned Anaesthetic Management or Surgical Timing After Disclosure of Gastric Ultrasound Findings
Tidsramme: On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.
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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. |
On the day of planned surgery, from the assessment before gastric ultrasound to immediately after disclosure of the ultrasound findings.
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Proportion of Participants With a Management Change Directly Attributed to Gastric Ultrasound Findings
Tidsramme: Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.
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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. |
Immediately after disclosure of gastric ultrasound findings, on the day of planned surgery.
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 019
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
There is currently no plan to share individual participant data.
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