Assessment for GEriatric Trauma Patients (PAGET)

April 17, 2019 updated by: University Hospital, Montpellier

The PAGET Survey : Pre-operative Assessment for GEriatric Trauma Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preoperative assessement for geriatric patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Realization of an ultrasound
Time Frame: 1 day
Incidence of FOCUS echography
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact on patient management
Time Frame: 1 day
Impact on patient management
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: xavier CAPDEVILA, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL17_0209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

nc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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