Clinical trial NCT02824692: 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
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: The incidence of significant clinical findings using focused ultrasound examination for the heart, lungs and abdomen in elderly patients before emergent surgery
timeFrame: up to 55 weeks
Secondary outcomes:
measure: 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
timeFrame: up to 55 weeks
measure: Changes in anesthetic management following the focused ultrasound examination
timeFrame: up to 55 weeks
measure: Overall satisfaction of anesthesiologists from the clinical data provided to them
timeFrame: up to 55 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Soroka University Medical Center
name: lior fuchs, MD
role: STUDY_DIRECTOR
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