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CompletedNCT03202589PAGETUpdated Apr 18, 2019

Assessment for GEriatric Trauma Patients

An observational study in Geriatric, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
65 Years and older
Sex
All
01

Study summary

Hip fracture is the second indication of surgical management elderly patients. It remains linked with a one-year mortality of 20%-25% according to diiferent governmental agencies, and the incidence reaches 30% for those over 80 years old.

The factors recognized and found to be most correlated with the survival / mortality ratio of patients are age, sex, intervention time, and prior health status.

The aim of a preoperative clinical evaluation is to estimate the benefit-risk balance of different clinical and technical managements and to prepare the postoperative patient outcome. During the last decade, management of hip fracture has improved mainly due to the different recommendations for a multidisciplinary management of perioperative procedures. However, none of them have yet highlighted FOCUS echocardiography as a "routine" examination of the preoperative evaluation as in most noncardiac surgeries.

The objective of this study is to evaluate the preoperative management of these patients: Clinical and biological evaluation, and to analyze the place that would have the FOCUS preoperative echocardiography in the choice of the anesthesia technique resulting from the patient evaluation.That study in a pre-requisite study to evaluate the incidence of FOCUS echocardiography realized by anesthesiologists in the preoperative period in order to define patient's outcome and anesthetic management.

Read the detailed description

The question is whether the pre-operative routine preoperative echographic evaluation would allow the correction or optimization of any comorbiditie, and / or lead to the modification of the anesthetic management of the patients. Feasibility studies have recently focused on the issue of ultrasound targeted at the patient's bedside. Thus, echocardiography data may have implications for anesthetic but also surgical management.

With the advent of ultraportable ultrasound machines, the limit to routine preoperative bedside use of the ultrasound tool appears to be resolved. The use of point-of-care ultrasounds has proven useful in the management of critical patients in emergency and intensive care units and is recommended in many countries.

Tthe investigators first want to assess the preoperative assessment of elderly and fragile patients admitted urgently for hip surgery. The investigators are setting up a multicenter observational questionnaire for consecutive patients. An electronic questionnaire is distributed via SurveyMonkey to various university hospitals, general hospitals and private institutions in France. The objective of this study is to evaluate the preoperative management of these patients: Clinical, biological evaluation, and analyze the current daily practice regarding the place of POC ultrasound preoperatively; the second question is to know if the choice of the anesthesia technique results from the patient's assessment.

The investigators hope to have a reliable survey of current practices on a group of 500 consecutive patients and then to determine with greater accuracy the first expected real hypothesis for a future prospective randomized multicenter study evaluating the use and impact of preoperative ultrasound assessment versus a control group for perioperative management, complications and outcome of patients undergoing hip fracture.

02

Conditions studied

  • Geriatric

Keywords

  • Preoperative assessement for geriatric patients
  • FOCUS Echocardiography
  • Orthopedic
  • Surgery
  • Geriatric
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Preoperative assessement for geriatric patients

Inclusion criteria

  • Male or female subject aged 66 or more
  • Undergoing hip surgery
  • Emergency surgery

Exclusion criteria

Exclusion Criteria:

    • Age less than 66years;
  • Non hip surgery
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (actual)
Patient registry
No

Interventions

  • OtherFOCUS Echocardiography

    FOCUS Echocardiography

06

What researchers measure

Primary outcomes

  1. Realization of an ultrasound

    Incidence of FOCUS echography

    Time frame: 1 day

Secondary outcomes

  1. Impact on patient management

    Impact on patient management

    Time frame: 1 day

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — nc

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03202589
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jun 28, 2017
Start date
Jan 1, 2017
Primary completion
Oct 1, 2018
Completion
Dec 31, 2018
Last update
Apr 18, 2019

Study contacts

xavier CAPDEVILA
study chair · University Hospital, Montpellier

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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