GeriatricPAGETNCT03202589
Assessment for GEriatric Trauma Patients
An observational study of Geriatric, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric
- What is being tested?
- FOCUS Echocardiography
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Preoperative assessement for geriatric patients
Who may be able to join
- Male or female subject aged 66 or more
- Undergoing hip surgery
- Emergency surgery
Who cannot join
- - Age less than 66years;
- Non hip surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Geriatric
- Being tested
- FOCUS Echocardiography
- Keywords
- Preoperative assessement for geriatric patients, FOCUS Echocardiography, Orthopedic, Surgery, Geriatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUS EchocardiographyOther
FOCUS Echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Realization of an ultrasound
Incidence of FOCUS echography
Measured: 1 day
Secondary outcomes (1)
Impact on patient management
Impact on patient management
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jan 2017
- Primary completion1 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xavier CAPDEVILA, Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202589
- Sponsor's protocol ID
- RECHMPL17_0209
- Acronym
- PAGET
- Status last verified
- Oct 2018
- First submitted
- 20 Jun 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: nc
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PAGET Survey : Pre-operative Assessment for GEriatric Trauma Patients
- ClinicalTrials.gov ID
- NCT03202589
- Acronym / sponsor ID
- PAGET / RECHMPL17_0209
- Conditions
- Geriatric
- Keywords
- Preoperative assessement for geriatric patients, FOCUS Echocardiography, Orthopedic, Surgery, Geriatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Preoperative assessement for geriatric patients
Key inclusion criteria (3 listed)
- Male or female subject aged 66 or more
- Undergoing hip surgery
- Emergency surgery
Key exclusion criteria (2 listed)
- - Age less than 66years;
- Non hip surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOCUS EchocardiographyFOCUS Echocardiography | Other | – |
Primary outcome
Realization of an ultrasound
Time frame: 1 day
Incidence of FOCUS echography
1 secondary outcome
Impact on patient management
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. nc
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xavier CAPDEVILA study chair
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realization of an ultrasound (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.