- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07898215
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Evaluation of the Relationship Between Preoperative Gastric Ultrasonography Findings and Left Ventricular Systolic Function in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
This study aims to investigate whether reduced heart function is associated with differences in stomach contents before elective coronary artery bypass graft (CABG) surgery. Patients undergoing elective cardiac surgery will be divided into two groups based on their left ventricular ejection fraction (LVEF), a measure of how well the heart pumps blood: patients with an LVEF below 40% and patients with an LVEF of 40% or higher. Before surgery, the researchers will use ultrasound to examine the stomach. They will assess the presence and amount of stomach contents using the Perlas grading system and ultrasound measurements of the gastric antrum. The main objective is to compare gastric ultrasound findings between the two groups. The researchers will also evaluate estimated gastric volume and the frequency of stomach findings associated with a higher risk of aspiration during anesthesia.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
This prospective, single-center, observational cohort study will investigate the association between left ventricular systolic function and preoperative gastric ultrasonography findings in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery.
A total of 50 patients will be enrolled consecutively and categorized into two groups according to preoperative left ventricular ejection fraction (LVEF): patients with LVEF <40% (n=25) and those with LVEF ≥40% (n=25). Group allocation will be based on pre-existing cardiac function without any study-related intervention. Demographic characteristics, relevant comorbidities, preoperative medication use, gastrointestinal symptoms, fasting duration, and echocardiographic findings will be documented to evaluate potential factors associated with gastric ultrasound findings.
Preoperative gastric ultrasonography will be performed before induction of general anesthesia by an anesthesiologist experienced in point-of-care gastric ultrasound. The examiner will be blinded to the patients' clinical and echocardiographic findings, including LVEF values. A 2-5 MHz convex transducer will be used to examine the gastric antrum in the epigastric region, using standard anatomical landmarks. Gastric assessment will be performed in both the supine and right lateral decubitus (RLD) positions.
Gastric contents will be assessed qualitatively using the Perlas grading system. Grade 0 indicates an empty antrum in both positions; Grade 1 indicates clear fluid visible only in the RLD position; and Grade 2 indicates clear fluid visible in both positions or the presence of solid or particulate gastric contents.
The gastric antral cross-sectional area (CSA) will be calculated in the RLD position using the anteroposterior and craniocaudal diameters according to the formula:
CSA (cm²) = (AP diameter × CC diameter × π) / 4.
For patients with clear gastric fluid, gastric volume will be estimated using the Perlas mathematical model:
Estimated gastric volume (mL) = 27.0 + (14.6 × CSA) - (1.28 × age). Estimated gastric volume will also be expressed in mL/kg. The volume estimation model will not be applied to patients with solid or thick particulate gastric contents.
A high-risk stomach will be defined as an estimated gastric volume greater than 1.5 mL/kg or the presence of solid or thick particulate gastric contents.
The study will evaluate the association between left ventricular systolic function and preoperative gastric ultrasound findings, with particular emphasis on gastric content characteristics, antral dimensions, and indicators of increased gastric aspiration risk.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: FADİME TOSUN, MD, Associate Professor
- Puhelinnumero: +90 532 237 52 84
- Sähköposti: fadimetosun@gmail.com
Opiskelupaikat
-
-
-
Adıyaman, Turkki (Türkiye), 02040
- Rekrytointi
- Adıyaman Training and Research Hospital
-
Ottaa yhteyttä:
- FADİME TOSUN, MD, Associate Professor
- Puhelinnumero: +90 532 237 52 84
- Sähköposti: fadimetosun@gmail.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
The study population will consist of 50 adult patients (aged ≥18 years) who are scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass at a single center. Eligible patients will be consecutively screened and enrolled after providing written informed consent. Participants will be categorized into two observational cohorts based on preoperative left ventricular ejection fraction (LVEF): LVEF <40% (n=25) and LVEF ≥40% (n=25). No randomization or experimental treatment assignment will be performed.
Kuvaus
Inclusion Criteria:
- Age ≥18 years.
- Scheduled for elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass.
- Willingness to participate in the study and provision of written informed consent.
Exclusion Criteria:
- Emergency surgery.
- History of upper gastrointestinal surgery.
- Known gastroparesis or severe gastrointestinal motility disorders.
- Active nausea or vomiting.
- Body mass index (BMI) >40 kg/m².
- History of gastroesophageal reflux disease (GERD).
- Inability to cooperate with gastric ultrasonography assessment.
- Refusal to participate in the study.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
Group L-EF - Reduced LVEF (LVEF <40%)
This cohort will include 25 adult patients scheduled for elective coronary artery bypass grafting (CABG) surgery with a preoperative left ventricular ejection fraction (LVEF) <40%, as determined by transthoracic echocardiography. Before induction of general anesthesia, patients will undergo gastric ultrasonography to assess Perlas grade, gastric antral cross-sectional area, estimated gastric volume, and the presence of high-risk gastric contents. No experimental therapeutic intervention will be administered. |
Preoperative gastric ultrasonography will be performed before anesthesia induction by an experienced anesthesiologist blinded to LVEF values. Using a 2-5 MHz convex probe, the gastric antrum will be examined in supine and right lateral decubitus positions. Perlas grade, antral cross-sectional area, and gastric contents will be recorded. Gastric volume will be estimated only in patients with clear fluid. A high-risk stomach will be defined as gastric volume >1.5 mL/kg or the presence of solid or thick particulate contents. The same protocol will be applied to both LVEF groups. |
|
Group N-EF - (LVEF ≥40%)
This cohort will include 25 adult patients scheduled for elective coronary artery bypass grafting (CABG) surgery with a preoperative left ventricular ejection fraction (LVEF) ≥40%, as determined by transthoracic echocardiography. Before induction of general anesthesia, patients will undergo gastric ultrasonography to assess Perlas grade, gastric antral cross-sectional area, estimated gastric volume, and the presence of high-risk gastric contents. No experimental therapeutic intervention will be administered. |
Preoperative gastric ultrasonography will be performed before anesthesia induction by an experienced anesthesiologist blinded to LVEF values. Using a 2-5 MHz convex probe, the gastric antrum will be examined in supine and right lateral decubitus positions. Perlas grade, antral cross-sectional area, and gastric contents will be recorded. Gastric volume will be estimated only in patients with clear fluid. A high-risk stomach will be defined as gastric volume >1.5 mL/kg or the presence of solid or thick particulate contents. The same protocol will be applied to both LVEF groups. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Distribution of Perlas Gastric Ultrasound Grades Between LVEF Groups
Aikaikkuna: Preoperatively, immediately before induction of general anesthesia
|
The primary outcome is the comparison of Perlas gastric ultrasound grade distributions between patients with LVEF <40% and LVEF ≥40%. Gastric contents will be assessed before anesthesia induction using the Perlas grading system: Grade 0, empty antrum in both supine and right lateral decubitus positions; Grade 1, clear fluid visible only in the right lateral decubitus position; and Grade 2, clear fluid visible in both positions. The number and percentage of patients in each grade will be compared between groups. |
Preoperatively, immediately before induction of general anesthesia
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Association Between LVEF and Estimated Gastric Volume (mL/kg)
Aikaikkuna: Preoperatively, immediately before induction of general anesthesia
|
The association between left ventricular ejection fraction (LVEF) and estimated gastric volume (mL/kg) will be evaluated in patients with clear gastric fluid. Gastric volume will be calculated using the Perlas formula: 27.0 + (14.6 × antral cross-sectional area in cm²) - (1.28 × age in years). The estimated volume will be divided by body weight to obtain mL/kg. The formula will not be applied to patients with solid or thick particulate gastric contents. |
Preoperatively, immediately before induction of general anesthesia
|
|
Gastric Antral Cross-Sectional Area (CSA)
Aikaikkuna: Preoperatively, immediately before induction of general anesthesia
|
Gastric antral cross-sectional area (CSA) will be measured using preoperative ultrasonography in the right lateral decubitus position. CSA will be calculated from the anteroposterior and craniocaudal diameters using the formula: CSA = (AP diameter × CC diameter × π) / 4. CSA values, expressed in cm², will be compared between patients with LVEF <40% and those with LVEF ≥40%. |
Preoperatively, immediately before induction of general anesthesia
|
|
Presence of Solid Gastric Contents
Aikaikkuna: Preoperatively, immediately before induction of general anesthesia
|
The presence of solid or thick particulate gastric contents will be assessed using preoperative gastric ultrasonography in the supine and right lateral decubitus positions. Findings will be recorded as present or absent. The number and percentage of patients with solid or thick particulate gastric contents will be compared between the LVEF <40% and LVEF ≥40% groups. |
Preoperatively, immediately before induction of general anesthesia
|
|
Prevalence of High-Risk Gastric Contents
Aikaikkuna: Preoperatively, immediately before induction of general anesthesia
|
A high-risk stomach will be defined as an estimated gastric volume >1.5 mL/kg or the presence of solid or thick particulate gastric contents on preoperative ultrasonography. Gastric volume will be estimated only in patients with clear fluid contents. The number and percentage of patients meeting the high-risk stomach criteria will be compared between the LVEF <40% and LVEF ≥40% groups. |
Preoperatively, immediately before induction of general anesthesia
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ADYU-AR-FT-04
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .