Incidence of Stomach Fullness and Associated Factors in Elective Surgical Patients

NCT06606782 | Completed

• 1 other identifier: 2020/202
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, observational study is to evaluate the incidence of residual gastric content in elective surgical patients who adhered to preoperative fasting guidelines and to investigate associated patient-related factors. Ultrasound (USG) has been identified as a valuable tool for assessing residual gastric content, and this study compares its efficacy against traditional questionnaire-based predictions. The study also examines the practicality and accuracy of different gastric volume estimation formulas and evaluates their correlation with aspiration risk. A total of 475 patients were enrolled in the study, of whom 404 completed both the questionnaire and USG examination. All participants were adult patients scheduled for elective surgery, following standard fasting protocols. The ultrasound examination assessed the presence of solid or fluid content in the stomach, and patients were classified according to qualitative Perlas risk scores (Grade 0: Low, Grade 1: Moderate, Grade 2: High risk of aspiration). The questionnaire collected patient-reported factors, such as symptoms of early satiety, history of cholelithiasis, and comorbidities like diabetes or chronic obstructive pulmonary disease (COPD). The primary objective of this study was to evaluate the efficacy of USG in detecting residual gastric content and compare it with questionnaire-based risk predictions. Logistic regression analysis identified early satiety and cholelithiasis as significant predictors of a full stomach and higher aspiration risk. Fasting duration was found to have a protective effect, reducing the likelihood of a full stomach. While many patient characteristics traditionally associated with delayed gastric emptying, such as age and diabetes, did not significantly correlate with the outcomes, early satiety and cholelithiasis proved to be key factors influencing gastric content. In addition, this study explored the performance of several gastric volume estimation formulas, including the Michiko, Bouvet, and Perlas 2019/2020 formulas. The findings indicated significant limitations in these formulas, with many patients being estimated to have negative gastric volumes, particularly by the Michiko and two of Perlas\' formulas. This highlights the inadequacies of current formulas in accurately predicting gastric volume, necessitating further refinement and development of new models that better account for physiological variability. Furthermore, the agreement between questionnaire-based predictions and USG findings was assessed using Cohen's Kappa, which indicated fair agreement (Kappa value = 0.282). This suggests that while the questionnaire can serve as a screening tool to identify patients at risk of aspiration, it cannot replace the accuracy and reliability of USG in clinical practice. Secondary objectives of the study included comparing the time-efficiency and ease of implementation between USG and the questionnaire-based assessments. USG proved to be more time-efficient, taking an average of 2.5 minutes per examination, compared to 3-5 minutes for completing the questionnaire. This speed, combined with its objective nature, underscores USG's value as a practical tool in the preoperative setting. In conclusion, USG was found to be an effective and efficient tool for assessing residual gastric content and predicting aspiration risk, outperforming traditional questionnaire-based assessments. The inadequacy of current gastric volume estimation formulas points to the need for further research to develop more accurate and context-specific assessment tools. Comprehensive preoperative evaluation incorporating USG and patient-reported symptoms may improve patient safety by reducing the risk of aspiration during elective surgery.

Conditions

Gastric Emptying; Preoperative Care; Preoperative Fasting; Elective Surgical Procedures; Ultrasonography

Keywords

Gastrointestinal Contents / diagnostic imaging*; Ultrasonography / methods*; Respiratory Aspiration / prevention & control*; Preoperative Care / methods; Risk Factors / evaluation; Patient-Reported Outcomes / methods; Humans

Outcome Measures

Primary Outcomes (1)

• Incidence of Full Stomach in Elective Surgical Patients as Assessed by Ultrasound

  The number of participants with full stomachs, as determined by the presence of solid content or fluid content using preoperative gastric ultrasound. Full stomach is defined as either solid content or clear fluid in the supine or right lateral decubitus positions.

  At the time of preoperative assessment, within 2 hours prior to surgery.

Secondary Outcomes (5)

• Correlation Between Preoperative Fasting Duration and Incidence of Full Stomach as Assessed by Ultrasound

  At the time of preoperative assessment, within 2 hours prior to surgery.

• Perlas Risk Score for Aspiration Risk as Assessed by Ultrasound

  At the time of preoperative assessment, within 2 hours prior to surgery.

• Agreement Between Questionnaire-Based Risk Prediction and Ultrasound Findings for Aspiration Risk

  At the time of preoperative assessment, within 2 hours prior to surgery.

• Time Efficiency of Ultrasound vs. Questionnaire-Based Gastric Content Assessment

  At the time of preoperative assessment, within 2 hours prior to surgery.

• Gastric Volume Estimation Using Multiple Formulae and Correlation with Aspiration Risk

  At the time of preoperative assessment, within 2 hours prior to surgery.

Study Arms (1)

Elective Surgery Patients

This cohort includes adult patients undergoing elective surgery who were assessed for residual gastric content using ultrasound and a preoperative questionnaire. All patients adhered to standard preoperative fasting guidelines prior to the assessment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery at the Recep Tayyip Erdoğan University Faculty of Medicine Rize Training and Research Hospital

You may qualify if:

• scheduled for elective surgery
• adhered to preoperative fasting guidelines
• provided written informed consent

You may not qualify if:

• children under 18 years of age
• pregnant women
• patients requiring emergency surgery
• patients with a history of previous stomach surgery
• patients who did not complete the sufficient fasting period (less than 8 hours)
• patients with whom reliable cooperation for questionnaire completion could not be established (e.g., inability to provide reliable answers)
• patients who could not be positioned on their right side due to clinical conditions
• patients in whom sufficient quality imaging of the gastric antrum could not be obtained

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Rize Training and Research Hospital

Rize, 53200, Turkey (Türkiye)

Location

Related Publications (18)

• Sugita M, Matsumoto M, Tsukano Y, Fukunaga C, Yamamoto T. Gastric emptying time after breakfast in healthy adult volunteers using ultrasonography. J Anesth. 2019 Dec;33(6):697-700. doi: 10.1007/s00540-019-02694-6. Epub 2019 Oct 19.

  PMID: 31630260 BACKGROUND

• Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.

  PMID: 21364462 BACKGROUND

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• Frykholm P, Disma N, Andersson H, Beck C, Bouvet L, Cercueil E, Elliott E, Hofmann J, Isserman R, Klaucane A, Kuhn F, de Queiroz Siqueira M, Rosen D, Rudolph D, Schmidt AR, Schmitz A, Stocki D, Sumpelmann R, Stricker PA, Thomas M, Veyckemans F, Afshari A. Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2022 Jan 1;39(1):4-25. doi: 10.1097/EJA.0000000000001599.

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MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: October 5, 2020
• Primary Completion: September 29, 2022
• Study Completion: October 10, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: Starting at January 2025, the IPD and analytical code will be shared.
• Access Criteria: Individual patient data (IPD) and/or analytical code may be shared upon request from researchers affiliated with recognized academic or research institutions, provided they have a valid organizational email address. Requests must include the name of the Ethics Committee, decision number, and date of approval. Sharing of data will be limited to de-identified and anonymized datasets to protect patient confidentiality. To further ensure patient privacy, informed consents will not be shared directly with individual researchers but may be reviewed by accredited institutions or journals for verification purposes. Data sharing will only be allowed for purposes such as systematic reviews, meta-analyses, or reanalysis of study findings, where the intent is to advance scientific knowledge while preserving the confidentiality of patient participants.

Locations

TU (1)