Point of Care Ultrasonography

July 17, 2019 updated by: Yael Ben Baruch Golan MD, Soroka University Medical Center

Influence of Point of Care Ultrasonography on Outcome of Inpatients Admitted To the Internal Ward

This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is to evaluate the benefit of adding POC US to the management of inpatients admitted to the internal ward with respiratory, cardiovascular or hemodynamic abnormalities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is to evaluate the benefit of adding POC US to the management of inpatients admitted to the internal ward with respiratory, cardiovascular or hemodynamic abnormalities.

This is a stage 1 pilot trial aimed to provide better understanding on the study population and study groups. This trial will comprise a total of 60 patients, 30 subjects on the intervention group and an equal number on the control group. The results of this pilot trial will be to design a larger trial and calculate a required sample size.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Soroka University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients admitted to internal ward
  2. Age ≥ 18
  3. No previous internal ward admission within the last 6 months

  4. At least one symptom or sign of the following on admission:

    • Respiratory abnormalities: Dyspnea, RR>20, O2 SAT<90% requirement of oxygen or non-invasive ventilation or mechanical ventilation
    • Cardiovascular abnormalities: Chest pain, HR>100, new/worsening peripheral edema, newly diagnosed ECG changes
    • Hemodynamic instability: SBP<90 mmHg or on vasopressor infusion or pre-renal azotemia

Exclusion Criteria:

  1. Patients with cognitive impairment or cannot sign informed consent.
  2. Subject enrolled in a different study
  3. Patients with end stage disease receiving Palliative/end of life treatments.
  4. Pregnant patients.
  5. Patients that were given a consult by one of the research members pre enrollment
  6. Patient under responsibility of one of the study team members

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group

All patients included in intervention group will be examined with an ultrasound machine with cardiac probe and vascular probe [Saote/ Mylab 5/ Italy] using both 2 dimensional and color Doppler imaging modalities according to our local point of care ultrasonography protocol.

Including demographic and medical data collection. Also, a wellbeing questionnaire will be filled by the investigator.
Device: Point Of Care Ultrasound
Examination with an ultrasound machine
Other Names:
  • MyLabfive
No Intervention: Control group
All patients included in the control group won't be examined with an ultrasound machine. Participation including demographic and medical data collection. Also, a wellbeing questionnaire will be filled by the investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospitalization
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Readmission rates
Time Frame: 15 months
15 months

Collaborators and Investigators

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

Sponsor

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 (Actual)

July 19, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

May 3, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor12115ctil
  • SCRC15008 (Other Identifier: Soroka CRC)

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.

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