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Breath analysis using the Aeonose to diagnose acute pulmonary embolism at the emergency department

Breath analysis using the Aeonose to diagnose acute pulmonary embolism at the emergency department

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25787
Enrollment
382
Registered
2017-06-19
Start date
2017-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary embolism, longembolie

Interventions

Subjects presenting at the emergency department with suspected acute pulmonary embolism and either increased D-dimer or Wells-score, will be asked to breathe normally into the Aeonose while wearing a

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Adult (>= 18 years) subjects on the emergency department with suspected pulmonary embolism - CTPA scan scheduled due to suspected pulmonary embolism - Being able to read, write and understand Dutch - Informed consent obtained

Exclusion criteria

Exclusion criteria: - No CTPA scan performed - Indeterminate CTPA scan results - No Wells-score and D-dimer available - Hemodynamic instability - Being unable to perform Aeonose measurement - Being unable to read, write or understand Dutch - No informed consent obtained prior to the breath analysis - Breath analysis performed after the CTPA scan - Breath analysis performed after start of treatment of pulmonary embolism - Diagnosis of pulmonary embolism within a period of 3 months after the visit to the emergency department where PE was excluded on CTPA

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy for the Aeonose to detect acute pulmonary embolism compared to computed tomography pulmonary angiography

Secondary

MeasureTime frame
- Differences in diagnostic accuracy for the Aeonose to detect acute pulmonary embolism compared to computed tomography pulmonary angiography for different locations and extent of the pulmonary emboli. - Differences in diagnostic accuracy of the Aeonose in detecting PE in the presence of several comorbidities. - The diagnostic accuracy of the Aeonose in predicting risk stratification of PE according to validated risk stratification scores (such as the Pulmonary Embolism Severity Index)

Contacts

Public ContactT.M. Fabius
T.Fabius@mst.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)