NCT03242733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 26, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

August 4, 2017

Last Update Submit

April 20, 2018

Conditions

Keywords

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ultrasound assessment of the component of residual gastric contents

    Before the induction of anesthesia (Baseline)

Study Arms (1)

Hip fracture patients

Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled.

Other: Ultrasound assessment of gastric contents

Interventions

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

Hip fracture patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 8424572BACKGROUND
  • 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.

    PMID: 17122571BACKGROUND
  • 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.

    PMID: 19304443BACKGROUND

MeSH Terms

Conditions

Hip FracturesGastroparesis

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jin-Young Hwang, MD,phD

    Seoul National University Boramae Hospital

    STUDY CHAIR

Central Study Contacts

Jin-Young Hwang, MD, phD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of Anesthesiology and Pain medicine

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

December 26, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations