Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869396
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2023-04-25
Brief Title:
Preoperative Echocardiography in Patients With Hip Fracture
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
Official Title:
Preoperative Echocardiography in Patients With Hip Fracture A Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of the study was to assess whether preoperative echocardiography affects time to surgery length of hospital stay and in hospital mortality in patients undergoing hip fracture surgery In the study entered two hundred fifty -five consecutive patients with hip fracture referred to a multidisciplinary hip fracture unit at a tertiary teaching hospital Other 717 patients referred before implementation of routine echocardiographic examination were considered as control group Echocardiography was performed in patients with systolic murmurs unstable clinical conditions recent decompensation of heart failure or hospital admission for coronary disease Time to surgery length of hospital stay LOS and in hospital mortality in patients underwent preoperative echocardiography high risk group were compared with patients who did not undergo echo low-risk group and with an historical group
Detailed Description:
The study is part of a project of Italian Health Ministry and Toscana Region -Regional Fund -2010-2316600- and was approved by Ethical Committee of Regione Toscana Written informed consent to treatment and collection of clinical data for research purposes was obtained at admission The study was conducted according to STROBE statements and performed in line with the principles of the Declaration of Helsinki
Between Jan 1 and May 31 2018 255 consecutive patients with hip fracture aged 70 years were referred to the Hip fracture Unit of a teaching hospital The diagnosis of hip fracture was made according to Orthopaedic Trauma Association classification All patients were evaluated by multidisciplinary hip fracture team according to a previously described protocol Demographic data comorbidities and functional status before trauma were recorded According to local evaluation protocol echocardiography was performed in patients with previously unknown systolic murmurs unstable cardiovascular clinical conditions recent within 6 months decompensation of heart failure or hospital admission for coronary disease high-risk group Results were compared with patients without these characteristics in whom echocardiography was not performed low-risk group Patients referred to hip fracture Unit in 2016 before implementation of echocardiography protocol were considered as control group
Between Jan 1 and May 31 2018 255 consecutive patients with hip fracture aged 70 years were referred to the Hip fracture Unit of a teaching hospital The diagnosis of hip fracture was made according to Orthopaedic Trauma Association classification All patients were evaluated by multidisciplinary hip fracture team according to a previously described protocol Demographic data comorbidities and functional status before trauma were recorded According to local evaluation protocol echocardiography was performed in patients with previously unknown systolic murmurs unstable cardiovascular clinical conditions recent within 6 months decompensation of heart failure or hospital admission for coronary disease high-risk group Results were compared with patients without these characteristics in whom echocardiography was not performed low-risk group Patients referred to hip fracture Unit in 2016 before implementation of echocardiography protocol were considered as control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None