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Preoperative Significant Clinical Findings Using Focused Ultrasound Examination

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ClinicalTrials.gov Identifier: NCT02824692
Recruitment Status : Unknown
Verified July 2016 by Dekel Lait MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Dekel Lait MD, Rambam Health Care Campus

Brief 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.

Condition or disease Intervention/treatment
Congestive Heart Failure Device: heart lungs and abdomen ultrasound

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 :

  1. Any changes in anesthetic management due to the examination findings
  2. 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Incidence of Significant Clinical Findings Using Focused Ultrasound Examination for the Heart, Lungs and Abdomen in Elderly Patients Before Emergent Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: heart lungs and abdomen ultrasound
    Other Name: VIVID5S GE device


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Significant clinical finding that will be missed or wrongly diagnosed by the anesthesiologist will be noted

  2. Changes in anesthetic management following the focused ultrasound examination [ Time Frame: up to 55 weeks ]
    The data will be collected and presented in a table stressing the changes made and their prevalence in the study population

  3. Overall satisfaction of anesthesiologists from the clinical data provided to them [ Time Frame: up to 55 weeks ]
    The data will be collected through a questionnaire containing numerical answers (between 1-5) regarding the usefulness and credibility of the ultra sound exam



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly male and female (over 65 years old) undergoing emergent (within 24 -72 hours from diagnosis) orthopedic or urological procedure.
Criteria

Inclusion Criteria:

  • male and female over 65 years
  • emergent operation (within 72 hours)
  • No echocardiographic examination in the past 6 months

Exclusion Criteria:

  • echocardiographic examination in the past 6 months
  • examination will detain surgery
  • unstable patients
  • no legal guardian, not eligible for informed consent
  • poor ultrasound image

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824692


Contacts
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Contact: dekel lait, MD 972-524-796216 dekelait@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Study Director: lior fuchs, MD Soroka University Medical Center
Publications:
15. Israel Ministry of health, guidelines for quality measurements 2016, pages 25-27

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Responsible Party: Dekel Lait MD, Dr., Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02824692    
Other Study ID Numbers: 0117-16-RMBCTIL
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases