The Impact of Point-of-Care Ultrasound

The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock

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.

Study Overview

• Status: Completed
• Conditions: Shock; Ultrasound
• Intervention / Treatment: Diagnostic test: Ultrasound

• Study Type: Observational
• Enrollment (Actual): 112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shock	Diagnostic test: Ultrasound; Point-of-care ultrasound examination by pulmonary and critical care fellow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Beth Israel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2014
• Primary Completion (Actual): April 17, 2015
• Study Completion (Actual): April 17, 2015

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 206-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No