Primary objective:Investigate whether the use of a digital drainage system leads to a shorter hospital stay in patients with primary pneumothorax, in whom clinical drainage is indicated. Secondary objectives: To investigate whether the use of a…
ID
Source
Brief title
Condition
- Pleural disorders
Synonym
Research involving
Sponsors and support
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
Description of the standard reference treatment. To describe the conservative
treatment, we will measure whether suction is applied and why, whether
provocative clamping is performed, how many chest X-rays are made during
treatment, and whether (and when) pleurodesis and surgery are performed.
Background summary
Treatment of the pneumothorax has two goals: removal of pleural air (leading to
expansion of the lung) and pleurodesis. Different treatment options are
available: a *wait and see* policy, manual aspiration, drainage, thoracoscopy
or surgery. Guidelines for treatment vary among different countries.
Until now, there have not been any clinical trials performed with digital
drainage in the treatment of primary pneumothorax. In postoperative patients,
digital drainage has shown reduction in hospital stay when compared to analogue
drainage. We hypothesize that digital drainage system leads to shorter hospital
stay in patients with primary pneumothorax.
Study objective
Primary objective:
Investigate whether the use of a digital drainage system leads to a shorter
hospital stay in patients with primary pneumothorax, in whom clinical drainage
is indicated.
Secondary objectives:
To 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 chest tube removal, leading to a aspiration, drainage,
thoracoscopy or surgery.
Study design
This is a multi-center, randomized trial. There is no blinding due to the
nature of the study. The trial will take place in 9 Dutch hospitals, mostly
training centers for pulmonologists. 190 Patients in both groups will be
collected within 2 years. Patients will randomly be assigned to analogue and
digital drainage.
Intervention
None.
Study burden and risks
Not applicable.
Boerhaavelaan 22
Haarlem 2035RC
NL
Boerhaavelaan 22
Haarlem 2035RC
NL
Listed location countries
Age
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36778.018.11 |
| OMON | NL-OMON21901 |