Ultrasound Assessment of Gastric Residual Volume in Obese Patients

NCT04544371 | Completed

• 1 other identifier: M420
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric emptying is a major risk factor for aspiration of gastric contents.Aspiration into the lungs represents a fatal complication that can occur during anesthesia. Not only gastric emptying importance to anesthetists is related to aspiration but also it is important to determine the systemic availability of substances given through the mouth. Delayed gastric emptying represents a major danger as it causes nausea and vomiting and prevents a return to oral feeding. Lastly it may cause morbidity and mortality. Both humoral and neural influences have their impact on emptying. Volume and composition of gastric food act as major determinants for the rate of gastric emptying. The effect of body weight on gastric emptying are inconsistent. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying. Ultrasound can be used perioperatively to asses gastric content and volume at bedside.

Conditions

Aspiration Pneumonia

Keywords

Gastric residual volume; Obese; Ultrasound; Aspiration

Outcome Measures

Primary Outcomes (1)

• measurement of gastric residual volume in semi-sitting position

  in cubic centimetre

  5 minutes preoperatively

Secondary Outcomes (6)

• measurement of gastric residual volume in right lateral position.

  5 minutes preoperatively

• Antral cross sectional area in semi-sitting position

  5 minutes preoperatively

• Antral cross sectional area in right lateral position

  5 minutes preoperatively

• volume of fluid aspirated from nasogastric tube

  1 minute after induction of anesthesia

• grade of aspiration risk

  5 minutes preoperatively

Other Outcomes (4)

• Age

  1 hour preoperatively

• Weight

  1 hour preoperatively

• Body mass index

  1 hour preoperatively

Study Arms (2)

normal weight patients

patients with body mass index =18-24.9 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area in semi-sitting and right lateral positions

Device: gastric ultrasound; Procedure: nasogastric tube insertion

obese patients

patients with body mass index \>30 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area semi-sitting and right lateral positions

Device: gastric ultrasound; Procedure: nasogastric tube insertion

Interventions

gastric ultrasound DEVICE

Focused gastric ultrasound was performed in semi-sitting position then right lateral position mindray curved transducer for examination of abdomen with low frequency (2-5 MHz) by a trained physician. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark

normal weight patients; obese patients

nasogastric tube insertion PROCEDURE

Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.

Also known as: Ryle tube

normal weight patients; obese patients

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This prospective observational study will be performed on 100 patients undergoing elective surgery in fayoum university

You may qualify if:

• Adult patients aged from 20 years to 60 years
• Patients scheduled for elective surgery after an 8-hour overnight fast after a light meal (200 ml milk, 50 g white cheese, and 120 g bread).
• American society of anesthesiologists physical status I-III.

You may not qualify if:

• Pregnancy
• Renal failure
• Liver cell failure
• History of upper GIT morbidity (hiatus hernia and gastric cancer)
• History of upper abdominal surgery.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate Egypt, 63514, Egypt

Location

Related Publications (5)

• Sun H, Wu CW, Zhang D, Makay O, Zhao Y, Carcofaro P, Kim HY, Dionigi G, Pino A, Caruso E, Pontin A, Pappalardo V. New Paradigms for Neural Monitoring in Thyroid Surgery. Surg Technol Int. 2019 May 15;34:79-86.

  PMID: 30664223 BACKGROUND

• Bakalinis E, Makris I, Demesticha T, Tsakotos G, Skandalakis P, Filippou D. Non-Recurrent Laryngeal Nerve and Concurrent Vascular Variants: A Review. Acta Med Acad. 2018 Nov;47(2):186-192. doi: 10.5644/ama2006-124.230.

  PMID: 30585070 BACKGROUND

• Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.

  PMID: 16563326 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

• Zaremba S, Shin CH, Hutter MM, Malviya SA, Grabitz SD, MacDonald T, Diaz-Gil D, Ramachandran SK, Hess D, Malhotra A, Eikermann M. Continuous Positive Airway Pressure Mitigates Opioid-induced Worsening of Sleep-disordered Breathing Early after Bariatric Surgery. Anesthesiology. 2016 Jul;125(1):92-104. doi: 10.1097/ALN.0000000000001160.

  PMID: 27171827 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Aspiration; Obesity

Interventions

Intubation, Gastrointestinal

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation; Therapeutics; Investigative Techniques

Study Officials

• Atef M sayed, MD

  Fayoum University

  PRINCIPAL INVESTIGATOR

• maged L Bolis, MD

  Fayoum University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: October 15, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 30, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

EG (1)