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)


De Nederlandse Pneumothorax Studie


- candidate number15443
- NTR NumberNTR4195
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2013
- Secondary IDsNL36778.018.11 (ABR) 
- Public TitleDe Nederlandse Pneumothorax Studie
- Scientific TitleDutch Pneumothorax Study
- ACRONYMDPS
- hypothesisDigital drainage systems lead to shorter hospital stay in patients with primary pneumothorax.
- Healt Condition(s) or Problem(s) studiedDrainage, Digital Care, Primary spontaneous pneumothorax
- Inclusion criteria- Pneumothorax with need for clinical drainage.
- Age >=18 years of age at the time of signature of the informed consent form.
- Able to sign informed consent.
- In the view of the investigator, the patient can and will comply with the requirements of the protocol.
- Exclusion criteria- Respiratory failure, defined as need for positive pressure ventilation.
- Uncontrolled bleeding tendency.
- Need for treatment in intensive care unit.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-okt-2012
- planned closingdate1-jul-2016
- Target number of participants190
- InterventionsPatients are randomized to receive a digital drainage system versus an analogue drainage system
- Primary outcomeLength of hospital stay, measured in days. If a patient stays in the hospital longer than necessary for the treatment of the pneumothorax (e.g., because the patient waits for a place in a nursing home), the length of hospital stay is defined as length of drainage.
- Secondary outcome- Investigate whether the use of a digital drainage system leads to a difference in treatment failure, defined as a recurrence in pneumothorax within twelve weeks after randomization, leading to a aspiration, drainage, thoracoscopy or surgery.
- TimepointsDay 0 = inclusion, randomisation Days 0-x = hospital stay Week 4 = visit outpatient clinic Week 12 = follow-up by phone
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES K Mooren
- CONTACT for SCIENTIFIC QUERIES K Mooren
- Sponsor/Initiator Kennemer Gasthuis
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-sep-2013 - 12-okt-2013


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