Congestive Heart FailureNCT02824692
Preoperative Significant Clinical Findings Using Focused Ultrasound Examination
An observational study of Congestive Heart Failure, run by Rambam Health Care Campus.
Trial summary
The purpose of this study is to determine whether a focused ultrasound examination for the heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant clinical findings in elderly patients before emergent surgery. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- heart lungs and abdomen ultrasound
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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
- Healthy volunteers accepted
- Older adult
Study population: Elderly male and female (over 65 years old) undergoing emergent (within 24 -72 hours from diagnosis) orthopedic or urological procedure.
Who may be able to join
- male and female over 65 years
- emergent operation (within 72 hours)
- No echocardiographic examination in the past 6 months
Who cannot join
- echocardiographic examination in the past 6 months
- examination will detain surgery
- unstable patients
- no legal guardian, not eligible for informed consent
- poor ultrasound image
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Incidence of Significant Clinical Findings Using Focused Ultrasound Examination for the Heart, Lungs and Abdomen in Elderly Patients Before Emergent Surgery
The purpose of this study is to determine whether a focused ultrasound examination for the heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant clinical findings in elderly patients before emergent surgery.
Read the detailed description
Emergent orthopedic and urological surgeries in the elderly population are characterized by high incidence of chronic diseases of the target population on one hand, and the time factor which limits the possibility to properly assess the preoperative condition on the other hand.
Therefore, anesthesiologist often perform these procedures such as hip replacement with insufficient data as compared to an elective case.
In Israel, a hip fracture must be operated on within 18 hours. This type of fracture is common to the elderly population who naturally suffer more from chronic diseases that might influence the management of anesthesia. Due to the emergent nature of the procedures involved, the patients are often operated on with only basic preoperative assessment such as ECG, chest x-ray and blood tests.
A more elaborated assessment, such as a valid echocardiography , evaluation of pleural effusion or the presence of ascites are often impossible to acquire due to inaccessibility of the echo lab (high burden, missing qualified personal ) or the availability of operation theater.
This is an observational pilot study in which the ability of a focused, bedside preoperative ultrasound examination preformed by a qualified anesthesiologist to expose significant clinical data will be evaluated.
Sample size: 30 patient. Male and female over the age 65. The examination will cover the heart (eg. volemic status, global systolic function, existence of severe valvular pathology, pericardial effusion), lungs (eg. pleural effusion, atelectasis, pneumothorax ) and abdomen ( e.g ascites ). It will be preformed at the patient bed using the VIVID5S General Electric device. All fields will be examined using the low frequency cardiac probe.
The data will be documented and saved electronically by the main investigator. All recorded ultrasound examination will be saved and coded with a number (no patient details).
All data collected will be validated by a physician experienced in the field. Any mismatch between the anesthesiologist records to the validated data will be documented.
Clinically significant findings will be documented and transferred (after validation) to the anesthesiologist performing the anesthesia (only senior anesthesiologist ).
On the following day, the anesthesiologist will document :
- Any changes in anesthetic management due to the examination findings
- Subjective report regarding the utility of the examination
Anesthetic changes and subjective report will be graphically documented. The anesthesiologist preforming the examination underwent the necessary qualifications to preform the exam. In any case, the preoperative examination and operation will not be held by the same anesthesiologist.
Patient enrollment to the study will be preformed at the ward, E.R or preoperative hall. It must be emphasized that in any case the performance of the operation will not be detained by the examination.
- Conditions
- Congestive Heart Failure
- Being tested
- heart lungs and abdomen ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart lungs and abdomen ultrasoundDevice
Also called VIVID5S GE device
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of significant clinical findings using focused ultrasound examination for the heart, lungs and abdomen in elderly patients before emergent surgery
Clinical findings that are considered significant (eg. pneumothorax, severe aortic stenosis, pericardial effusion) will be documented and presented in a table - demonstrating their prevalence among the study population.
Measured: up to 55 weeks
Secondary outcomes (3)
Sensitivity and specificity of a qualified anesthesiologist in the diagnosis of clinically significant findings in focused ultra sound examination for the heart, lung and abdoman
Significant clinical finding that will be missed or wrongly diagnosed by the anesthesiologist will be noted
Measured: up to 55 weeks
Changes in anesthetic management following the focused ultrasound examination
The data will be collected and presented in a table stressing the changes made and their prevalence in the study population
Measured: up to 55 weeks
Overall satisfaction of anesthesiologists from the clinical data provided to them
The data will be collected through a questionnaire containing numerical answers (between 1-5) regarding the usefulness and credibility of the ultra sound exam
Measured: up to 55 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dekel Lait MD, Rambam Health Care Campus
- Investigators
- lior fuchs, MD, Study director, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824692
- Sponsor's protocol ID
- 0117-16-RMBCTIL
- Status last verified
- Jul 2016
- First submitted
- 18 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Barber RL, Fletcher SN. A review of echocardiography in anaesthetic and peri-operative practice. Part 1: impact and utility. Anaesthesia. 2014 Jul;69(7):764-76. doi: 10.1111/anae.12663. Epub 2014 Apr 28.
PubMed 24773366Canty DJ, Royse CF, Kilpatrick D, Williams DL, Royse AG. The impact of pre-operative focused transthoracic echocardiography in emergency non-cardiac surgery patients with known or risk of cardiac disease. Anaesthesia. 2012 Jul;67(7):714-20. doi: 10.1111/j.1365-2044.2012.07118.x. Epub 2012 Mar 27.
PubMed 22452367Kertai MD, Bountioukos M, Boersma E, Bax JJ, Thomson IR, Sozzi F, Klein J, Roelandt JR, Poldermans D. Aortic stenosis: an underestimated risk factor for perioperative complications in patients undergoing noncardiac surgery. Am J Med. 2004 Jan 1;116(1):8-13. doi: 10.1016/j.amjmed.2003.07.012.
PubMed 14706659Subramani S, Tewari A. Pre-operative echocardiography: Evidence or experience based utilization in non-cardiac surgery? J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):313-5. doi: 10.4103/0970-9185.137258. No abstract available.
PubMed 25190935Oren-Grinberg A, Talmor D, Brown SM. Focused critical care echocardiography. Crit Care Med. 2013 Nov;41(11):2618-26. doi: 10.1097/CCM.0b013e31829e4dc5.
PubMed 23989172Jasudavisius A, Arellano R, Martin J, McConnell B, Bainbridge D. A systematic review of transthoracic and transesophageal echocardiography in non-cardiac surgery: implications for point-of-care ultrasound education in the operating room. Can J Anaesth. 2016 Apr;63(4):480-7. doi: 10.1007/s12630-015-0524-7. Epub 2015 Oct 30.
PubMed 26514983Michelena HI, Abel MD, Suri RM, Freeman WK, Click RL, Sundt TM, Schaff HV, Enriquez-Sarano M. Intraoperative echocardiography in valvular heart disease: an evidence-based appraisal. Mayo Clin Proc. 2010 Jul;85(7):646-55. doi: 10.4065/mcp.2009.0629.
PubMed 20592170Canty DJ, Royse CF, Kilpatrick D, Bowyer A, Royse AG. The impact on cardiac diagnosis and mortality of focused transthoracic echocardiography in hip fracture surgery patients with increased risk of cardiac disease: a retrospective cohort study. Anaesthesia. 2012 Nov;67(11):1202-9. doi: 10.1111/j.1365-2044.2012.07300.x. Epub 2012 Sep 5.
PubMed 22950446Canty DJ, Royse CF. Audit of anaesthetist-performed echocardiography on perioperative management decisions for non-cardiac surgery. Br J Anaesth. 2009 Sep;103(3):352-8. doi: 10.1093/bja/aep165. Epub 2009 Jun 23.
PubMed 19549642Luttrell K, Nana A. Effect of Preoperative Transthoracic Echocardiogram on Mortality and Surgical Timing in Elderly Adults with Hip Fracture. J Am Geriatr Soc. 2015 Dec;63(12):2505-2509. doi: 10.1111/jgs.13840. Epub 2015 Dec 11.
PubMed 26659463Canty DJ, Royse CF, Kilpatrick D, Bowman L, Royse AG. The impact of focused transthoracic echocardiography in the pre-operative clinic. Anaesthesia. 2012 Jun;67(6):618-25. doi: 10.1111/j.1365-2044.2012.07074.x. Epub 2012 Feb 21.
PubMed 22352785Alsaddique A, Royse AG, Royse CF, Mobeirek A, El Shaer F, AlBackr H, Fouda M, Canty DJ. Repeated Monitoring With Transthoracic Echocardiography and Lung Ultrasound After Cardiac Surgery: Feasibility and Impact on Diagnosis. J Cardiothorac Vasc Anesth. 2016 Apr;30(2):406-12. doi: 10.1053/j.jvca.2015.08.033. Epub 2015 Aug 29.
PubMed 26723882Ng A, Swanevelder J. Perioperative echocardiography for non-cardiac surgery: what is its role in routine haemodynamic monitoring? Br J Anaesth. 2009 Jun;102(6):731-4. doi: 10.1093/bja/aep100. No abstract available.
PubMed 19451153Loxdale SJ, Sneyd JR, Donovan A, Werrett G, Viira DJ. The role of routine pre-operative bedside echocardiography in detecting aortic stenosis in patients with a hip fracture. Anaesthesia. 2012 Jan;67(1):51-54. doi: 10.1111/j.1365-2044.2011.06942.x. Epub 2011 Oct 24.
PubMed 2202366715. Israel Ministry of health, guidelines for quality measurements 2016, pages 25-27
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Significant Clinical Findings Using Focused Ultrasound Examination for the Heart, Lungs and Abdomen in Elderly Patients Before Emergent Surgery
- ClinicalTrials.gov ID
- NCT02824692
- Acronym / sponsor ID
- 0117-16-RMBCTIL
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- 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 purpose of this study is to determine whether a focused ultrasound examination for the heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant clinical findings in elderly patients before emergent surgery.
Detailed description
Emergent orthopedic and urological surgeries in the elderly population are characterized by high incidence of chronic diseases of the target population on one hand, and the time factor which limits the possibility to properly assess the preoperative condition on the other hand.
Therefore, anesthesiologist often perform these procedures such as hip replacement with insufficient data as compared to an elective case.
In Israel, a hip fracture must be operated on within 18 hours. This type of fracture is common to the elderly population who naturally suffer more from chronic diseases that might influence the management of anesthesia. Due to the emergent nature of the procedures involved, the patients are often operated on with only basic preoperative assessment such as ECG, chest x-ray and blood tests.
A more elaborated assessment, such as a valid echocardiography , evaluation of pleural effusion or the presence of ascites are often impossible to acquire due to inaccessibility of the echo lab (high burden, missing qualified personal ) or the availability of operation theater.
This is an observational pilot study in which the ability of a focused, bedside preoperative ultrasound examination preformed by a qualified anesthesiologist to expose significant clinical data will be evaluated.
Sample size: 30 patient. Male and female over the age 65. The examination will cover the heart (eg. volemic status, global systolic function, existence of severe valvular pathology, pericardial effusion), lungs (eg. pleural effusion, atelectasis, pneumothorax ) and abdomen ( e.g ascites ). It will be preformed at the patient bed using the VIVID5S General Electric device. All fields will be examined using the low frequency cardiac probe.
The data will be documented and saved electronically by the main investigator. All recorded ultrasound examination will be saved and coded with a number (no patient details).
All data collected will be validated by a physician experienced in the field. Any mismatch between the anesthesiologist records to the validated data will be documented.
Clinically significant findings will be documented and transferred (after validation) to the anesthesiologist performing the anesthesia (only senior anesthesiologist ).
On the following day, the anesthesiologist will document :
- Any changes in anesthetic management due to the examination findings
- Subjective report regarding the utility of the examination
Anesthetic changes and subjective report will be graphically documented. The anesthesiologist preforming the examination underwent the necessary qualifications to preform the exam. In any case, the preoperative examination and operation will not be held by the same anesthesiologist.
Patient enrollment to the study will be preformed at the ward, E.R or preoperative hall. It must be emphasized that in any case the performance of the operation will not be detained by the examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly male and female (over 65 years old) undergoing emergent (within 24 -72 hours from diagnosis) orthopedic or urological procedure.
Key inclusion criteria (3 listed)
- male and female over 65 years
- emergent operation (within 72 hours)
- No echocardiographic examination in the past 6 months
Key exclusion criteria (5 listed)
- echocardiographic examination in the past 6 months
- examination will detain surgery
- unstable patients
- no legal guardian, not eligible for informed consent
- poor ultrasound image
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 |
|---|---|---|
| heart lungs and abdomen ultrasoundAlso: VIVID5S GE device | Device | – |
Primary outcome
The incidence of significant clinical findings using focused ultrasound examination for the heart, lungs and abdomen in elderly patients before emergent surgery
Time frame: up to 55 weeks
Clinical findings that are considered significant (eg. pneumothorax, severe aortic stenosis, pericardial effusion) will be documented and presented in a table - demonstrating their prevalence among the study population.
3 secondary outcomes
Sensitivity and specificity of a qualified anesthesiologist in the diagnosis of clinically significant findings in focused ultra sound examination for the heart, lung and abdoman
Time frame: up to 55 weeks
Changes in anesthetic management following the focused ultrasound examination
Time frame: up to 55 weeks
Overall satisfaction of anesthesiologists from the clinical data provided to them
Time frame: up to 55 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 24773366Barber RL, Fletcher SN. A review of echocardiography in anaesthetic and peri-operative practice. Part 1: impact and utility. Anaesthesia. 2014 Jul;69(7):764-76. doi: 10.1111/anae.12663. Epub 2014 Apr 28.
- Background: PubMed 22452367Canty DJ, Royse CF, Kilpatrick D, Williams DL, Royse AG. The impact of pre-operative focused transthoracic echocardiography in emergency non-cardiac surgery patients with known or risk of cardiac disease. Anaesthesia. 2012 Jul;67(7):714-20. doi: 10.1111/j.1365-2044.2012.07118.x. Epub 2012 Mar 27.
- Background: PubMed 14706659Kertai MD, Bountioukos M, Boersma E, Bax JJ, Thomson IR, Sozzi F, Klein J, Roelandt JR, Poldermans D. Aortic stenosis: an underestimated risk factor for perioperative complications in patients undergoing noncardiac surgery. Am J Med. 2004 Jan 1;116(1):8-13. doi: 10.1016/j.amjmed.2003.07.012.
- Background: PubMed 25190935Subramani S, Tewari A. Pre-operative echocardiography: Evidence or experience based utilization in non-cardiac surgery? J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):313-5. doi: 10.4103/0970-9185.137258. No abstract available.
- Background: PubMed 23989172Oren-Grinberg A, Talmor D, Brown SM. Focused critical care echocardiography. Crit Care Med. 2013 Nov;41(11):2618-26. doi: 10.1097/CCM.0b013e31829e4dc5.
- Background: PubMed 26514983Jasudavisius A, Arellano R, Martin J, McConnell B, Bainbridge D. A systematic review of transthoracic and transesophageal echocardiography in non-cardiac surgery: implications for point-of-care ultrasound education in the operating room. Can J Anaesth. 2016 Apr;63(4):480-7. doi: 10.1007/s12630-015-0524-7. Epub 2015 Oct 30.
- Background: PubMed 20592170Michelena HI, Abel MD, Suri RM, Freeman WK, Click RL, Sundt TM, Schaff HV, Enriquez-Sarano M. Intraoperative echocardiography in valvular heart disease: an evidence-based appraisal. Mayo Clin Proc. 2010 Jul;85(7):646-55. doi: 10.4065/mcp.2009.0629.
- Background: PubMed 22950446Canty DJ, Royse CF, Kilpatrick D, Bowyer A, Royse AG. The impact on cardiac diagnosis and mortality of focused transthoracic echocardiography in hip fracture surgery patients with increased risk of cardiac disease: a retrospective cohort study. Anaesthesia. 2012 Nov;67(11):1202-9. doi: 10.1111/j.1365-2044.2012.07300.x. Epub 2012 Sep 5.
- Background: PubMed 19549642Canty DJ, Royse CF. Audit of anaesthetist-performed echocardiography on perioperative management decisions for non-cardiac surgery. Br J Anaesth. 2009 Sep;103(3):352-8. doi: 10.1093/bja/aep165. Epub 2009 Jun 23.
- Background: PubMed 26659463Luttrell K, Nana A. Effect of Preoperative Transthoracic Echocardiogram on Mortality and Surgical Timing in Elderly Adults with Hip Fracture. J Am Geriatr Soc. 2015 Dec;63(12):2505-2509. doi: 10.1111/jgs.13840. Epub 2015 Dec 11.
- Background: PubMed 22352785Canty DJ, Royse CF, Kilpatrick D, Bowman L, Royse AG. The impact of focused transthoracic echocardiography in the pre-operative clinic. Anaesthesia. 2012 Jun;67(6):618-25. doi: 10.1111/j.1365-2044.2012.07074.x. Epub 2012 Feb 21.
- Background: PubMed 26723882Alsaddique A, Royse AG, Royse CF, Mobeirek A, El Shaer F, AlBackr H, Fouda M, Canty DJ. Repeated Monitoring With Transthoracic Echocardiography and Lung Ultrasound After Cardiac Surgery: Feasibility and Impact on Diagnosis. J Cardiothorac Vasc Anesth. 2016 Apr;30(2):406-12. doi: 10.1053/j.jvca.2015.08.033. Epub 2015 Aug 29.
- Individual participant dataSharing planned: Undecided
Related trials for Congestive Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
lior fuchs, MD study director
Soroka University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Rambam Health Care Campus.
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 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: status not confirmed, as of the sponsor's last update on 7 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dekel lait, MD (972-524-796216, dekelait@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of significant clinical findings using focused ultrasound examination for the heart, lungs and abdomen in elderly patients before emergent surgery (time frame: up to 55 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824692, which also lists 20 linked publications.
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 7 Jul 2016.