No registrations found.
ID
Source
Brief title
Health condition
Primary spontaneous pneumothorax
(primaire spontane pneumothorax)
Drainage system (drainage systeem), digital versus analogue (digitaal vs analoog)
Sponsors and support
(investigator-initiated study)
Intervention
Outcome measures
Primary outcome
Length 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.
Background summary
N/A
Study objective
Digital drainage systems lead to shorter hospital stay in patients with primary pneumothorax.
Study design
Day 0 = inclusion, randomisation
Days 0-x = hospital stay
Week 4 = visit outpatient clinic
Week 12 = follow-up by phone
Intervention
Patients are randomized to receive a digital drainage system versus an analogue drainage system
Kennemer Gasthuis
Boerhaavelaan 22
K Mooren
Haarlem 2035 RC
The Netherlands
k.mooren@kg.nl
Kennemer Gasthuis
Boerhaavelaan 22
K Mooren
Haarlem 2035 RC
The Netherlands
k.mooren@kg.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4022 |
| NTR-old | NTR4195 |
| CCMO | NL36778.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39210 |