Point of Care Ultrasonography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemodynamic Instability, Respiratory Abnormalities, Cardiovascular Abnormalities

Intervention / Treatment
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* Device: Point Of Care Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to internal ward Age ≥ 18 No previous internal ward admission within the last 6 months 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: Patients with cognitive impairment or cannot sign informed consent. Subject enrolled in a different study Patients with end stage disease receiving Palliative/end of life treatments. Pregnant patients. Patients that were given a consult by one of the research members pre enrollment Patient under responsibility of one of the study team members

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* Examination with an ultrasound machine<br>* Other names: MyLabfive;|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rates |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soroka University Medical Center, Heart Failure, cardiovascular, Point Of Care Ultrasonography