Point of Care Ultrasonography

Not Applicable

Completed

• Conditions: Respiratory Abnormalities; Cardiovascular Abnormalities; Hemodynamic Instability
• Interventions: Device: Point Of Care Ultrasound

• Registration Number: NCT02436317
• Lead Sponsor: Soroka University Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-05-03
• Study First Posted: 2015-05-06
• Study Start: 2015-07-19
• Status Verified: 2019-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Point Of Care Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Length of hospitalization	1 month

Secondary Outcome Measures

Name	Time	Method
Readmission rates	15 months

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel