NCT03276364

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

September 6, 2017

Last Update Submit

September 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Shock

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Point-of-care ultrasound examination by pulmonary and critical care fellow

Shock

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Could undergo both a POCUS and bioreactance assessment within 6 hours of admission from the emergency department or transfer from a medical floor. * Shock was defined as either systolic blood pressure less than 90 mmHg or 40 mmHg below baseline, necessity for vasopressors to maintain mean arterial pressure greater than 65 mmHg, or any evidence of acute organ hypoperfusion that was evident at the time of study enrollment as judged by the treating physician. * The patient needed to be in shock at the time of POCUS and bioreactance testing at time of enrollment in order to be included.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

July 21, 2014

Primary Completion

April 17, 2015

Study Completion

April 17, 2015

Last Updated

September 8, 2017

Record last verified: 2017-09