EchocardiographyPrEchoNCT05862493
Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)
A study testing FOCUS echocardiography in people with Echocardiography and Hip Fractures, run by Umeå University.
Trial summary
The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Echocardiography, Hip Fractures, Risk Assessment
- What is being tested?
- FOCUS echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2)
Who cannot join
- Metastatic cancer and/or suspect pathological fracture.
- Concurrent other fracture/surgery.
- Reoperation within 72 hours from primary operation.
- Severe dementia.
- Preoperative echocardiography for other reason than participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications.
Read the detailed description
Hip fracture surgery is a common procedure, and despite progress in perioperative management, cardiac complications are common, and the post-operative mortality remains high. In this geriatric patient population, cardiac disease as well as varying degrees of dehydration is common, and preoperative knowledge of these conditions have a key role in enabling a proactive perioperative hemodynamic management. However, clinical assessment is surprisingly unreliable and has been shown to easily fail to identify significant cardiac disease and lack of venous return.
Transthoracic echocardiography (TTE) is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery. In a preoperative practice, the use of focused cardiac ultrasound (FOCUS) enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making. Furthermore, measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension.
Patients scheduled for daytime hip fracture surgery will be screened for eligibility.
Random allocation (1:1 allocation ratio) of patients to receive standard care (control group) or standard care + preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization (intervention group). Registration of pre- and intraoperative blood pressure, as well as post-operative complications and mortality will be conducted.
Primary outcome measure: Intraoperative hemodynamic instability defined as MAP < 60 mmHg.Secondary outcome measures: Time to surgery, length of hospital stay, renal failure, cardiac complications (myocardial ischemia, heart failure, post-operative atrial fibrillation, pulmonary edema, pulmonary embolism), 7-,30- and 90-day mortality.
- Being tested
- FOCUS echocardiography
- Keywords
- FOCUS, Point-of-care echocardiography
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUS echocardiographyDiagnostic test
Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs
| Study group | Role | What they receive |
|---|---|---|
| Standard management | No intervention | Standard preoperative management, no preoperative TTE |
| FOCUS optimization | Experimental | Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings. Receives: Diagnostic Test: FOCUS echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure drop
Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg
Measured: From date of randomization up to 4 hours
Secondary outcomes (6)
Change of blood pressure level
Blood pressure (MAP) change from baseline BP
Measured: From date of randomization up to 4 hours
Lowest level of blood pressure (MAP)
Absolut lowest blood pressure (MAP) from baseline BP
Measured: From date of randomization up to 4 hours
Acute kidney failure
Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria
Measured: From date of randomization up to 48 hours
Myocardial injury
Myocardial injury defined as a raise in serum high-sensitive troponin with at least 5 ng/l-1 to a minimum concentration of at least 20 ng/l-1
Measured: From date of randomization up to 48 hours
Readmission
Readmission to hospital within 7 days
Measured: From date of randomization up to 7 days
Mortality
Postoperative mortality at 7-, 30- and 90-days
Measured: From date of randomization up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open label, superiority trial with a 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomi P Myrberg, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862493
- Sponsor's protocol ID
- Dnr 2022-05628-01
- Acronym
- PrEcho
- Status last verified
- Dec 2023
- First submitted
- 27 Apr 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SPSS data file will be available for a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05862493
- Acronym / sponsor ID
- PrEcho / Dnr 2022-05628-01
- Keywords
- FOCUS, Point-of-care echocardiography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 May 2023 (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.
The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications.
Detailed description
Hip fracture surgery is a common procedure, and despite progress in perioperative management, cardiac complications are common, and the post-operative mortality remains high. In this geriatric patient population, cardiac disease as well as varying degrees of dehydration is common, and preoperative knowledge of these conditions have a key role in enabling a proactive perioperative hemodynamic management. However, clinical assessment is surprisingly unreliable and has been shown to easily fail to identify significant cardiac disease and lack of venous return.
Transthoracic echocardiography (TTE) is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery. In a preoperative practice, the use of focused cardiac ultrasound (FOCUS) enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making. Furthermore, measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension.
Patients scheduled for daytime hip fracture surgery will be screened for eligibility.
Random allocation (1:1 allocation ratio) of patients to receive standard care (control group) or standard care + preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization (intervention group). Registration of pre- and intraoperative blood pressure, as well as post-operative complications and mortality will be conducted.
Primary outcome measure: Intraoperative hemodynamic instability defined as MAP < 60 mmHg.Secondary outcome measures: Time to surgery, length of hospital stay, renal failure, cardiac complications (myocardial ischemia, heart failure, post-operative atrial fibrillation, pulmonary edema, pulmonary embolism), 7-,30- and 90-day mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open label, superiority trial with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Standard management | No intervention | –Standard preoperative management, no preoperative TTE |
| FOCUS optimization | Experimental | Diagnostic Test: FOCUS echocardiographyStandard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2)
Key exclusion criteria (5 listed)
- Metastatic cancer and/or suspect pathological fracture.
- Concurrent other fracture/surgery.
- Reoperation within 72 hours from primary operation.
- Severe dementia.
- Preoperative echocardiography for other reason than participation in the study.
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 echocardiographyPreoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs | Diagnostic test | FOCUS optimization |
Primary outcome
Blood pressure drop
Time frame: From date of randomization up to 4 hours
Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg
6 secondary outcomes
Change of blood pressure level
Time frame: From date of randomization up to 4 hours
Lowest level of blood pressure (MAP)
Time frame: From date of randomization up to 4 hours
Acute kidney failure
Time frame: From date of randomization up to 48 hours
Myocardial injury
Time frame: From date of randomization up to 48 hours
Readmission
Time frame: From date of randomization up to 7 days
Mortality
Time frame: From date of randomization up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No. SPSS data file will be available for a reasonable request
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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.
Tomi P Myrberg, MD, PhD principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS echocardiography in people with Echocardiography and Hip Fractures, run by Umeå University.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomi P Myrberg, MD, PhD (+4692028339, tomi.myrberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure drop (time frame: From date of randomization up to 4 hours). 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 8 Dec 2023.