Characteristics of Patients With Missed Pulmonary Embolism in the ED: A Three Year Experience

June 18, 2015 updated by: Christoph Keil, University Hospital, Basel, Switzerland

The clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging procedures performed for other purposes. (1) Depending on the clinical presentation, the case fatality rate for acute pulmonary embolism ranges from 1% up to 60%. Due to the often non-specific presentation, especially in mild to moderate acute pulmonary embolism PE is often underdiagnosed. Chest pain and shortness of breath are the two most common symptoms associated with pulmonary embolism, together these symptoms are responsible for approximately 10 million emergency department visits in the United States of America (US) (2). The aim of this study was to determine the sensitivity and specificity of diagnosing pulmonary embolism (PE) at the emergency department (ED) of the University Hospital Basel and the investigators have therefore retrospectively analyzed all cases with excluded or proven PE in our institution in the last three years. Data sets from the institute of radiology, the institute of pathology and the ED are consistently available from January 2011 until the present day and were screened for pulmonary embolism in discharge reports. Data from the ED include all patients between January 2011 and December 2013 that presented to the ED and received either an ECG or any form of thoracic imaging. Particular attention was paid to patients with PE in the discharge report. The third set of data includes all patients with PE as cause of death or as a secondary diagnosis in the autopsy report. After comparing the three sets of data to each other the investigators tried to determine the sensitivity and specificity of PE diagnosis at the ED respectively the rate of missed diagnoses. A PE was seen as missed if it is detected 24h after the patient presented to the ED or if it was detected at another department after the patient was transferred from the ED.

Study Overview

Status

Completed

Conditions

Missed Pulmonary Embolism at the Emergency Department

Intervention / Treatment

Other: detection of pulmonary embolism

Study Type

Observational

Enrollment (Actual)

1251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patientes presented to the ED in the specified timeframe who are at risk for pulmonary embolism

Description

Inclusion Criteria:

patients 18 years of age or older,
presented to the ED between January 2011 and March 2014,
who received an ECG or any form of thoracic imaging.

Exclusion Criteria:

patients below 18 years of age, as well as patients referred to the ED with suspected PE by departments within UHBS, other hospitals, or other healthcare providers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
in hospital mortality Time Frame: 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
initial ED diagnosis Time Frame: 24 hours	24 hours
characteristics of patients with missed PE Time Frame: 30 days	30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Estimate)