The Impact of Point-of-Care Ultrasound

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03276364
• Collaborator: Beth Israel Medical Center (Other)
• Enrollment: 112
• Actual Duration (Months): 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasound; Shock	Diagnostic Test: Ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock
• Actual Study Start Date: Jul 21, 2014
• Actual Primary Completion Date: Apr 17, 2015
• Actual Study Completion Date: Apr 17, 2015

Arms and Interventions

Arm	Intervention/Treatment
Shock	Diagnostic Test: Ultrasound; Point-of-care ultrasound examination by pulmonary and critical care fellow

Outcome Measures

Primary Outcome Measures

1. Fluid responsiveness [Immediately subsequent to performance of a point-of-care ultrasound exam]

   Increase of stroke volume index greater than 10% following passive leg raise testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Montefiore Medical Center
• Beth Israel Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel G. Fein, Assistant Professor of Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03276364
• Other Study ID Numbers: 206-13
• First Posted: Sep 8, 2017
• Last Update Posted: Sep 8, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shock

Study Results

No Results Posted as of Sep 8, 2017