Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED

Withdrawn

• Conditions: Pulmonary Embolism
• Interventions: Other: Echocardiogram

• Registration Number: NCT02356120
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study will be to evaluate the measurement of tricuspid annular plane systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the pulmonary arteries (CTPA)

Detailed Description

This will be a prospective observational cohort study aimed at determining the utility and reproducibility of TAPSE, in patients who present to the emergency department with suspected pulmonary embolism (PE). The gold standard diagnostic test for PE is computed tomography of the pulmonary arteries (CTPA). Any patient for whom a CTPA is ordered because of suspected PE is eligible for study inclusion

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Concern for PE by attending physician and CTPA ordered

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Exclusion Criteria

• If patient is under the age of 18, a prisoner, or a ward of the state
• CTPA ordered but not performed

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected Pulmonary Embolus	Echocardiogram	Patients with suspected pulmonary embolus who are getting a CTPA

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of TAPSE (The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis)	0 days	The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis

Secondary Outcome Measures

Name	Time	Method
Inter-Observer Agreement (To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.)	0 days	To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States