Assessment for GEriatric Trauma Patients (PAGET)

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: Completed
• Conditions: Geriatric
• Intervention / Treatment: Other: FOCUS Echocardiography

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: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Realization of an ultrasound	Incidence of FOCUS echography	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on patient management	Impact on patient management	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Chair: xavier CAPDEVILA, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Surgery; Geriatric; Orthopedic; Preoperative assessement for geriatric patients; FOCUS Echocardiography
• Other Study ID 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