NCT02436317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

April 21, 2015

Last Update Submit

July 17, 2019

Conditions

Respiratory AbnormalitiesCardiovascular AbnormalitiesHemodynamic Instability

Keywords

Point Of Care UltrasonographySoroka University Medical CenterHeart Failurecardiovascular

Outcome Measures

Primary Outcomes (1)

  • Length of hospitalization

    1 month

Secondary Outcomes (1)

  • Readmission rates

    15 months

Study Arms (2)

Study group

EXPERIMENTAL

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.

Device: Point Of Care Ultrasound

Control group

NO INTERVENTION

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.

Interventions

Point Of Care UltrasoundDEVICE

Examination with an ultrasound machine

Also known as: MyLabfive
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related Publications (16)

  • 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. doi: 10.1667/RR0763.1.

    PMID: 17722996RESULT

  • 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 Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.

    PMID: 22681860RESULT

  • Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

    PMID: 21345104RESULT

  • 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.

    PMID: 25468845RESULT

  • 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 Physicians. J Am Soc Echocardiogr. 2010 Dec;23(12):1225-30. doi: 10.1016/j.echo.2010.10.005.

    PMID: 21111923RESULT

  • 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, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

    PMID: 22392031RESULT

  • 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.

    PMID: 23989172RESULT

  • Kobal SL, Atar S, Siegel RJ. Hand-carried ultrasound improves the bedside cardiovascular examination. Chest. 2004 Sep;126(3):693-701. doi: 10.1378/chest.126.3.693.

    PMID: 15364744RESULT

  • 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(8):2013-8. doi: 10.1016/s0735-1097(01)01288-8.

    PMID: 11419879RESULT

  • 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. doi: 10.1097/00000542-200401000-00006.

    PMID: 14695718RESULT

  • 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.ejim.2011.10.009. Epub 2011 Nov 9.

    PMID: 22284252RESULT

  • 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. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.

    PMID: 24998674RESULT

  • 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):843-52. doi: 10.1111/acem.12435.

    PMID: 25176151RESULT

  • 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. 2003 Sep;16(9):901-5. doi: 10.1016/S0894-7317(03)00426-7.

    PMID: 12931101RESULT

  • 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. Chest. 2013 Dec;144(6):1868-1875. doi: 10.1378/chest.13-0882.

    PMID: 23948720RESULT

  • 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.

    PMID: 19586543RESULT

MeSH Terms

Conditions

Cardiovascular AbnormalitiesHeart Failure

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yael Golan

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 6, 2015

Study Start

July 19, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

IL(1)