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Point of Care Ultrasonography

Primary Purpose

Respiratory Abnormalities, Cardiovascular Abnormalities, Hemodynamic Instability

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Point Of Care Ultrasound

About this trial

This is an interventional diagnostic trial for Respiratory Abnormalities focused on measuring Point Of Care Ultrasonography, Soroka University Medical Center, Heart Failure, cardiovascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Soroka University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Length of hospitalization

Secondary Outcome Measures

Readmission rates

Full Information

NCT ID

NCT02436317

First Posted

April 21, 2015

Last Updated

July 17, 2019

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02436317

Brief Title

Point of Care Ultrasonography

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 19, 2015 (Actual)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Abnormalities, Cardiovascular Abnormalities, Hemodynamic Instability

Keywords

Point Of Care Ultrasonography, Soroka University Medical Center, Heart Failure, cardiovascular

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Point Of Care Ultrasound

Other Intervention Name(s)

MyLabfive

Intervention Description

Examination with an ultrasound machine

Primary Outcome Measure Information:

Title

Length of hospitalization

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Readmission rates

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Soroka University Medical Center

City

Beer Sheva

Country

Israel

12. IPD Sharing Statement

Citations:

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Citation

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Point of Care Ultrasonography

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