Clinical trial NCT02436317: Point of Care Ultrasonography
Official title: Influence of Point of Care Ultrasonography on Outcome of Inpatients Admitted To the Internal Ward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Abnormalities
Cardiovascular Abnormalities
Hemodynamic Instability
Keywords: Point Of Care Ultrasonography
Soroka University Medical Center
Heart Failure
cardiovascular
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospitalization
timeFrame: 1 month
Secondary outcomes:
measure: Readmission rates
timeFrame: 15 months
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References:
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