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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03276364
Other study ID # 206-13
Secondary ID
Status Completed
Phase N/A
First received September 6, 2017
Last updated September 6, 2017
Start date July 21, 2014
Est. completion date April 17, 2015

Study information

Verified date September 2017
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness.

In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date April 17, 2015
Est. primary completion date April 17, 2015
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow was on duty.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound
Point-of-care ultrasound examination by pulmonary and critical care fellow

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Beth Israel Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Fluid responsiveness Increase of stroke volume index greater than 10% following passive leg raise testing Immediately subsequent to performance of a point-of-care ultrasound exam
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