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Trial: NCT02824692 [RDF]

Label NCT02824692
Slug nct02824692
Trialid NCT02824692
Lookup name NCT02824692
Lastchanged date July 2, 2016
Firstreceived results date
Firstreceived date June 18, 2016
Id info nct id NCT02824692
Overall status Not yet recruiting
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 30
Number of arms
Is section 801
Is fda regulated No
Brief title Preoperative Significant Clinical Findings Using Focused Ultrasound Examination
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 type Observational
Id info nct alias
Completion date July 2017
Verification date July 2016
Why stopped
Id info org study id 0117-16-RMBCTIL
Required header url
Study design Observational Model: Case-Only, Time Perspective: Prospective
Source Rambam Health Care Campus
Primary completion date March 2017
Brief summary
Number of groups 1
Required header download date processed this data on September 07, 2016
Phase N/A
Start date July 2016
Has expanded access No
Biospec descr
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.
Condition browse c5aed89ec049e8f52ef4dbb260ea6fe2
Intervention browse None
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact dekel lait, MD (Contact)
Overall contact backup None
Sponsor group c02e1aaf1725422cb71aa43659f78eae
Oversight info Israel: Ethics Commission (Oversight_info)
Eligibility a960cef4fcc4c0003071adfc088ffa9d
Keywords None
Conditions Congestive Heart Failure
Locations None
Links None
Results references None
Arm groups None
Location countries None
Interventions heart lungs and abdomen ultrasound (Intervention)
Secondary outcomes 0725ed8c5f10635030fde6b27e993fed, 98073c170f7ab2482222be1f18ebb6a2, b1275336e35d4707ad682a339c210e99
References None
Primary outcomes 964d88e542762af891f1788bf04d453f
Removed countries None
Overall officials d8d684a7a1a1c870213e4604ee30bf25