Correlation of Preoperative Gastric Residual Volume With Body Mass Index and Aspiration Risk in Laparoscopic Bariatric Surgery

NCT07032207 | Recruiting

• 1 other identifier: FSMTRH-BT01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a chronic, complex disease defined by the World Health Organization (WHO) as the excessive accumulation of fat in the body that can harm health. Since 1975, the prevalence of obesity has been increasing worldwide, making it a significant public health issue. Body mass index (BMI) is important in diagnosing obesity. BMI is calculated by dividing a person's weight (kg) by the square of their height (m²). BMI: weight (kg) / height² (m²). According to the WHO, a BMI between 30.0-34.9 kg/m² is classified as Class 1 obesity, between 35.0-39.9 kg/m² as Class 2 obesity, between 40-49.9 kg/m² as Class 3 obesity, and ≥50.0 kg/m² as super obesity. Obesity is closely related to increasing morbidity and mortality worldwide, and in obese patients, the incidence of diseases such as type 2 diabetes, hypertension, cardiovascular disease, dyslipidemia, coronary heart disease, obstructive sleep apnea, asthma, depression, other psychiatric disorders, and gastroesophageal reflux has increased. Treatment options for obesity include lifestyle changes, specific diets, diet-drug combinations, metabolic and various bariatric surgical options. Among these treatment options, metabolic and bariatric surgical procedures are considered the most effective methods for weight loss. Aspiration of gastric contents is a significant perioperative complication that can cause up to 9% of anesthesia-related deaths. Due to delayed gastric emptying in obese patients, the risk of aspiration is higher compared to non-obese patients. In obese patients, preoperative anesthesia management is more challenging, and the risk of pulmonary aspiration is greater. Since obesity is an independent risk factor for patients with a full stomach, and airway management can be difficult in these patients, it is essential to assess the aspiration risk in the preoperative period. Anesthesia guidelines recommend that to improve the quality and effectiveness of anesthesia care and reduce the severity of potential complications related to perioperative pulmonary aspiration of gastric contents, adults and children should be allowed to drink clear liquids up to 2 hours before elective surgery, and solid food consumption should be prohibited 6 hours before elective surgery. Recently, with the integration of ultrasound into anesthesia practice, ultrasound has been applied in various surgical procedures and clinical conditions. The use of ultrasound to evaluate the risk of aspiration in the preoperative period and to determine the residual gastric volume is increasingly being used in clinical practice. The use of gastric ultrasound to assess aspiration risk has also been increasing in pediatric patient groups and pregnant patients, similar to obese patient groups. In this study, the investigators' aim is to determine the relationship between BMI, fasting duration, and aspiration risk by assessing the gastric residual volume in the preoperative period through gastric ultrasonography in patients with obesity who will undergo bariatric surgery.

Conditions

Obesity; Gastric Ultrasound; Gastric Residual Volume; Body Mass Index (BMI)

Keywords

obesity; gastric ultrasound; gastric residual volume; body mass index; aspiration

Outcome Measures

Primary Outcomes (1)

• The correlation between BMI, gastric residual volume, and aspiration risk.

  Higher BMI levels may be associated with increased gastric residual volume (GRV), which in turn can elevate the risk of pulmonary aspiration, especially during anesthesia. Understanding the correlation between BMI, GRV, and aspiration risk is crucial for developing safer preoperative fasting guidelines and optimizing care in high-risk patients.

  5 minutes

Secondary Outcomes (1)

• The correlation between fasting duration, gastric residual volume, and the risk of aspiration

  5 minutes

Eligibility Criteria

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

Study Population

Patients who will undergo bariatric surgery under general anesthesia in elective conditions

You may qualify if:

• Patients who will undergo bariatric surgery under general anesthesia in elective conditions
• Patients in ASA II-III groups, with BMI \> 35 kg/m², and aged between 18-65 years
• Patients who have provided informed consent

You may not qualify if:

• Patients under 18 years of age, over 65 years of age, or in ASA IV-V groups
• Pregnancy
• Patients with upper gastrointestinal (GI) abnormalities such as hiatal hernia and gastric tumors
• Patients with a recent history of upper GI bleeding (within the last 12 months), previous stomach and esophagus surgeries, or abnormal anatomy of the upper gastrointestinal tract
• Patients using medications that affect gastric motility or other related conditions
• Patients with uncontrolled diabetes
• Patients who require emergency surgery
• Patients with advanced cardiac, renal, pulmonary, or hepatic failure
• Patients who refuse to participate and do not provide informed consent

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

Related Publications (11)

• Sherwin M, Katz D. Using gastric ultrasound to assess gastric content in the pregnant patient. BJA Educ. 2021 Nov;21(11):404-407. doi: 10.1016/j.bjae.2021.08.001. Epub 2021 Sep 23. No abstract available.

  PMID: 34707884 BACKGROUND

• Moake MM, Presley BC, Hill JG, Wolf BJ, Kane ID, Busch CE, Jackson BF. Point-of-Care Ultrasound to Assess Gastric Content in Pediatric Emergency Department Procedural Sedation Patients. Pediatr Emerg Care. 2022 Jan 1;38(1):e178-e186. doi: 10.1097/PEC.0000000000002198.

  PMID: 32769837 BACKGROUND

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 BACKGROUND

• Bouvet L, Desgranges FP, Aubergy C, Boselli E, Dupont G, Allaouchiche B, Chassard D. Prevalence and factors predictive of full stomach in elective and emergency surgical patients: a prospective cohort study. Br J Anaesth. 2017 Mar 1;118(3):372-379. doi: 10.1093/bja/aew462.

  PMID: 28203726 BACKGROUND

• Mahajan V, Hashmi J, Singh R, Samra T, Aneja S. Comparative evaluation of gastric pH and volume in morbidly obese and lean patients undergoing elective surgery and effect of aspiration prophylaxis. J Clin Anesth. 2015 Aug;27(5):396-400. doi: 10.1016/j.jclinane.2015.03.004. Epub 2015 Apr 30.

  PMID: 25935831 BACKGROUND

• Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.

  PMID: 19512861 BACKGROUND

• Singhal V, Youssef S, Misra M. Use of sleeve gastrectomy in adolescents and young adults with severe obesity. Curr Opin Pediatr. 2020 Aug;32(4):547-553. doi: 10.1097/MOP.0000000000000927.

  PMID: 32692052 BACKGROUND

• Aaseth J, Ellefsen S, Alehagen U, Sundfor TM, Alexander J. Diets and drugs for weight loss and health in obesity - An update. Biomed Pharmacother. 2021 Aug;140:111789. doi: 10.1016/j.biopha.2021.111789. Epub 2021 May 31.

  PMID: 34082399 BACKGROUND

• Ruban A, Stoenchev K, Ashrafian H, Teare J. Current treatments for obesity. Clin Med (Lond). 2019 May;19(3):205-212. doi: 10.7861/clinmedicine.19-3-205.

  PMID: 31092512 BACKGROUND

• De Lorenzo A, Gratteri S, Gualtieri P, Cammarano A, Bertucci P, Di Renzo L. Why primary obesity is a disease? J Transl Med. 2019 May 22;17(1):169. doi: 10.1186/s12967-019-1919-y.

  PMID: 31118060 BACKGROUND

• Schetz M, De Jong A, Deane AM, Druml W, Hemelaar P, Pelosi P, Pickkers P, Reintam-Blaser A, Roberts J, Sakr Y, Jaber S. Obesity in the critically ill: a narrative review. Intensive Care Med. 2019 Jun;45(6):757-769. doi: 10.1007/s00134-019-05594-1. Epub 2019 Mar 19.

  PMID: 30888440 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ARZU YILDIRIM AR, Associate Professor

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

BUSRA TANACIOGLU, Research Assistant M.D

CONTACT

+905333866352; busra.tanacioglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant MD

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 22, 2025
• Study Start: June 30, 2024
• Primary Completion: January 15, 2026
• Study Completion: April 15, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)