Point of Care Ultrasonography

Soroka University Medical Center

Status: Completed

Conditions: Hemodynamic Instability; Cardiovascular Abnormalities; Respiratory Abnormalities

Treatments: Device: Point Of Care Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02436317

sor12115ctil

SCRC15008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Study group

Experimental group

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.

Treatment:

Device: Point Of Care Ultrasound

Control group

No Intervention group

Description:

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.