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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03242733
Other study ID # 20170804/10/2017/8
Secondary ID
Status Recruiting
Phase
First received August 4, 2017
Last updated April 20, 2018
Start date December 26, 2017
Est. completion date September 2019

Study information

Verified date April 2018
Source SMG-SNU Boramae Medical Center
Contact Jin-Young Hwang, MD, phD
Phone 82-10-9553-0916
Email mistyblue15@naver.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasound assessment of gastric contents
Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.

Locations

Country Name City State
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Lienhart A, Auroy Y, Péquignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. — View Citation

Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
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