search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number27426
- NTR NumberNTR6536
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jun-2017
- Secondary IDsK15-20 METC Twente
- Public TitleBreath analysis using the Aeonose to diagnose acute pulmonary embolism at the emergency department
- Scientific TitleBreath analysis using the Aeonose to diagnose acute pulmonary embolism at the emergency department
- ACRONYMAeonose-PE study
- hypothesisPulmonary embolism (PE) needs to be ruled out with high certainty when suspected. The gold standard to diagnose PE is a computed tomography pulmonary angiography (CTPA) scan. This scan is relatively expensive and requires potentially harmful irradiation and infusion of contrast fluid. To decrease the need for a CTPA scan, current guidelines recommend the use of clinical decision tools (such as the Wells and Geneva scores) and D-dimer (a degradation product of fibrin) testing. If either the clinical decision tool or the D-dimer value is increased, a CTPA scan has to be performed. Though this strategy has significantly decreased the need of CTPA scans, PE is still diagnosed in less than 25% of the cases (i.e. the positive predictive value is <25%). Therefore, the search to additional tools that can exclude PE fast and cheap, but with high certainty, continues. It can be hypothesized that PE results in changes in the exhaled volatile organic compounds. These changes in “breath pattern” may be detectable by the electronic nose technology such as the Aeonose (The eNose Company, Zutphen, the Netherlands). Using the Aeonose in subjects with suspected PE might therefore decrease the need of CTPA scans.
- Healt Condition(s) or Problem(s) studiedPulmonary embolism
- 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- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jul-2017
- planned closingdate1-jul-2019
- Target number of participants382
- InterventionsSubjects 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 nose clip. The results of the Aeonose measurements are compared with the results of the CTPA scan.
- Primary outcomeDiagnostic accuracy for the Aeonose to detect acute pulmonary embolism compared to computed tomography pulmonary angiography
- Secondary outcome- 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)
- TimepointsT=0: Visit to the emergecy department due to suspected acute pulmonary embolism: Aeonose measurement and CTPA scan
T=3: If the CTPA scan excludes pulmonary embolism, the patient records of the patient will be checked 3 months after the visit to the emergency department on the diagnosis of pulmonary embolism during this follow up period. If present, the subject will be excluded from the study.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES T.M. Fabius
- CONTACT for SCIENTIFIC QUERIES T.M. Fabius
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
The Enose company
- Publications
- Brief summaryAcute pulmonary embolism (PE) is a potentially lethal disease that needs to be ruled out when suspected. The gold standard to diagnose PE is a computed tomography pulmonary angiography (CTPA) scan which is relatively expensive and requires irradiation and contrast agent infusion. Unfortunately, PE is ruled out in >75% of the CTPA scans. It can be hypothesized that PE results in changes in the exhaled volatile organic compounds. This changes in “breath pattern” may be detectable by electronic nose technology such as the Aeonose (The eNose Company, Zutphen, the Netherlands). Using the Aeonose in subjects with suspected PE might therefore decrease the need of CTPA scans. This study aims to assess the diagnostic accuracy of the Aeonose in detecting PE compared to CTPA in patients at the emergency department who are suspected of PE and scheduled for a CTPA scan.
- Main changes (audit trail)
- RECORD19-jun-2017 - 26-jul-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl