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

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ClinicalTrials.gov Identifier: NCT03242733
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

Brief 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.

Condition or disease Intervention/treatment
Hip Fractures 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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


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.




Primary Outcome Measures :
  1. Ultrasound assessment of the presence of gastric contents. [ Time Frame: Before the induction of anesthesia (Baseline) ]
    The presence of of gastric contents is assessed by using ultrasonography; yes/no


Secondary Outcome Measures :
  1. Ultrasound assessment of the component of residual gastric contents [ Time Frame: Before the induction of anesthesia (Baseline) ]
    The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Who has hip fracture and agrees with the purpose of the study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242733


Contacts
Contact: Jin-Young Hwang, MD, phD 82-10-9553-0916 mistyblue15@naver.com

Locations
Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Jin-Young Hwang, M.D.    +82-2-870-2518    mistyblue15@naver.com   
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
Investigators
Study Chair: Jin-Young Hwang, MD,phD Seoul National University Boramae Hospital

Publications:
Responsible Party: Jin-Young Hwang, Associate professor, Department of Anesthesiology and Pain medicine, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03242733     History of Changes
Other Study ID Numbers: 20170804/10/2017/8
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin-Young Hwang, SMG-SNU Boramae Medical Center:
Gastroparesis

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries