Preoperative Significant Clinical Findings Using Focused Ultrasound Examination

July 2, 2016 updated by: Dekel Lait MD, Rambam Health Care Campus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 55 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 55 weeks
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
up to 55 weeks
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
up to 55 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Study Director: lior fuchs, MD, Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 18, 2016

First Submitted That Met QC Criteria

July 2, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0117-16-RMBCTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congestive Heart Failure

Clinical Trials on heart lungs and abdomen ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe