Point-of-care Gastric Ultrasound for Fracture Surgery

NCT05728242 | Recruiting

• 1 other identifier: 142-2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). More research is necessary to define elective surgeries with a possible risk of aspiration. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by measuring and evaluating gastric volume and content with USG in the preoperative operating room.

Conditions

Pneumonia, Aspiration; Gastric Content; Fractures, Bone

Keywords

gastric ultrasound; aspiration pneumonia; gastric emptying; fracture surgery

Outcome Measures

Primary Outcomes (2)

• gastric volume(ml)

  gastric volume calculated with gastric volume (mL) = 27.0 + 14.6 x right-lat CSA - 1.28 x age and Antral cross-sectional area = anterior posterior diameter (D1) × cranio-caudal diameter (D2) × π/4 . Evaluation is done as over 1,5 ml /kg grade 2; if 1,5- 0,8 ml/kg, grade 1; ˂ 0,8 ml/kg, grade 0

  preoperative, only one measurement

• gastric content

  Grade 0, no gastric content within the antrum at both positions ( supine and right lateral decubitis(RLD)); Grade 1, gastric content is seen only at RLD position; Grade 2 gastric content was detected in both positions

  preoperative, only one examination

Secondary Outcomes (2)

• nausea or vomiting

  postoperative 24 hour

• aspiration pneumonia

  postoperative 48 hours

Interventions

Gastric ultrasound DIAGNOSTIC_TEST

Preoperative gastric antrum examination to detect gastric content (empty, liquid, or solid) and measure gastric volume

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have been admitted to fracture surgery within 3 days of the trauma

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status classification I to III
• Patients necessitating surgery after traumatic fracture

You may not qualify if:

• Patients with a body mass index over 35
• Diseases that may lead to gastroparesis (
• Known gastroesophageal reflux disease
• Known autonomic neuropathy
• Known diabetes mellitus
• Known or operated esophageal abnormalities
• History of gastric surgery
• Acute gastric or peptic ulcus
• Pregnancy
• Preoperative narcotic analgesic usage
• Known connective tissue disorders like scleroderma or amyloidosis
• Known hiatal hernia
• Known gallbladder and choledochal stone

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Alakkad H, Kruisselbrink R, Chin KJ, Niazi AU, Abbas S, Chan VW, Perlas A. Point-of-care ultrasound defines gastric content and changes the anesthetic management of elective surgical patients who have not followed fasting instructions: a prospective case series. Can J Anaesth. 2015 Nov;62(11):1188-95. doi: 10.1007/s12630-015-0449-1. Epub 2015 Aug 4.

  PMID: 26239668 RESULT

• Zhang G, Huang X, Shui Y, Luo C, Zhang L. Ultrasound to guide the individual medical decision by evaluating the gastric contents and risk of aspiration: A literature review. Asian J Surg. 2020 Dec;43(12):1142-1148. doi: 10.1016/j.asjsur.2020.02.008. Epub 2020 Mar 11.

  PMID: 32171605 RESULT

MeSH Terms

Conditions

Pneumonia, Aspiration; Fractures, Bone

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Officials

• Berna Caliskan, MD

  Haseki Training and Research Hospital Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna Caliskan, MD

CONTACT

+905067108770; caliskan.b@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion: July 15, 2025
• Study Completion: July 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)