Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture

Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip

Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures
• Intervention / Treatment: Other: Ultrasound assessment of gastric contents

Detailed Description

In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion.

In the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Recruiting
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Who has hip fracture and agrees with the purpose of the study

Description

Inclusion Criteria:

• Who has hip fracture and agrees with the purpose of the study

Exclusion Criteria:

• gastrointestinal pathology
• history of any type of gastrectomy
• gastrointestinal anomaly

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hip fracture patients; Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled.	Other: Ultrasound assessment of gastric contents; Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound assessment of the presence of gastric contents.	The presence of of gastric contents is assessed by using ultrasonography; yes/no	Before the induction of anesthesia (Baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound assessment of the component of residual gastric contents	The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content	Before the induction of anesthesia (Baseline)

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center
• Investigators: Study Chair: Jin-Young Hwang, MD,phD, Seoul National University Boramae Hospital

Publications and helpful links

General Publications

• Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
• Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
• Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Gastroparesis
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: 20170804/10/2017/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No