Point of Care Ultrasonography

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436317
• Other study ID #: sor12115ctil
• Secondary ID: SCRC15008
• Status: Completed
• Phase: N/A
• Start date: July 19, 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Congenital Abnormalities
• Hemodynamic Instability
• Respiratory Abnormalities

Intervention

Device:
• Point Of Care Ultrasound
Examination with an ultrasound machine

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (16)

Al Deeb M, Barbic S, Featherstone R, Dankoff J, Barbic D. Point-of-care ultrasonography for the diagnosis of acute cardiogenic pulmonary edema in patients presenting with acute dyspnea: a systematic review and meta-analysis. Acad Emerg Med. 2014 Aug;21(8) — View Citation

Fedson S, Neithardt G, Thomas P, Lickerman A, Radzienda M, DeCara JM, Lang RM, Spencer KT. Unsuspected clinically important findings detected with a small portable ultrasound device in patients admitted to a general medicine service. J Am Soc Echocardiogr — View Citation

Hothi SS, Sprigings D, Chambers J. Point-of-care cardiac ultrasound in acute medicine--the quick scan. Clin Med (Lond). 2014 Dec;14(6):608-11. doi: 10.7861/clinmedicine.14-6-608. — View Citation

Kobal SL, Atar S, Siegel RJ. Hand-carried ultrasound improves the bedside cardiovascular examination. Chest. 2004 Sep;126(3):693-701. Review. — View Citation

Labovitz AJ, Noble VE, Bierig M, Goldstein SA, Jones R, Kort S, Porter TR, Spencer KT, Tayal VS, Wei K. Focused cardiac ultrasound in the emergent setting: a consensus statement of the American Society of Echocardiography and American College of Emergency — View Citation

Laursen CB, Sloth E, Lambrechtsen J, Lassen AT, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Focused sonography of the heart, lungs, and deep veins identifies missed life-threatening conditions in admitted patients with acute respiratory symptoms. C — View Citation

Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med — View Citation

Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. — View Citation

Mjolstad OC, Dalen H, Graven T, Kleinau JO, Salvesen O, Haugen BO. Routinely adding ultrasound examinations by pocket-sized ultrasound devices improves inpatient diagnostics in a medical department. Eur J Intern Med. 2012 Mar;23(2):185-91. doi: 10.1016/j. — View Citation

Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review. — View Citation

Oren-Grinberg A, Talmor D, Brown SM. Focused critical care echocardiography. Crit Care Med. 2013 Nov;41(11):2618-26. doi: 10.1097/CCM.0b013e31829e4dc5. Review. — View Citation

Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de González A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospecti — View Citation

Preston DL, Ron E, Tokuoka S, Funamoto S, Nishi N, Soda M, Mabuchi K, Kodama K. Solid cancer incidence in atomic bomb survivors: 1958-1998. Radiat Res. 2007 Jul;168(1):1-64. — View Citation

Spencer KT, Anderson AS, Bhargava A, Bales AC, Sorrentino M, Furlong K, Lang RM. Physician-performed point-of-care echocardiography using a laptop platform compared with physical examination in the cardiovascular patient. J Am Coll Cardiol. 2001 Jun 15;37 — View Citation

Thiel SW, Kollef MH, Isakow W. Non-invasive stroke volume measurement and passive leg raising predict volume responsiveness in medical ICU patients: an observational cohort study. Crit Care. 2009;13(4):R111. doi: 10.1186/cc7955. Epub 2009 Jul 8. — View Citation

Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppma — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization		1 month
Secondary	Readmission rates		15 months