Pneumothorax
Conditions
Keywords
Pneumothorax, Iatrogenic, Chest tube, Pleuralvent
Brief summary
The aim of this clinical trial is to compare the efficiency and analgesic use in the therapy of iatrogenic Pneumothorax when using the Pleuralvent™ system in comparison with large bore chest tubes (catheter 16F).
Detailed description
Rationale: Pneumothorax is a common, usually invasively treated, disorder. The usual methods of treatment are needle aspiration (14-16 G needles) or chest drainage (16+ F catheters). A third therapeutic option is the use of small calibre catheters (\< 16F). According to some studies, the success rates of these methods are comparable. These catheters have the same success rate as large bore chest tubes and treatment with them is less painful for patients. The use of Heimlich valves allows for increased patient mobility - or even out-patient treatment. According to a review by the European Respiratory Society, nowadays there is an availability of systems which are part of advanced intervention techniques. These devices are designed for ease of insertion allowing for the full mobility of patients. It is, however, not clear whether treatment with these new systems is less painful. The aim of this clinical trial is to compare the efficiency and analgesic use in the therapy of iatrogenic Pneumothorax when using the Pleuralvent™ system in comparison with large bore chest tubes (catheter 16F). Process: Following the completion of the initial screening (fulfilling of both inclusion and exclusion criteria) and the signing of informed consent, a patient with iatrogenic pneumothorax (PNO) will be treated with, according to randomisation, either the Pleuralvent™ system or with a large bore chest tube - 16F. A control chest X-ray will be performed immediately after the introduction of the therapeutic method and following 3 days of therapy. If no signs of PNO are present, the therapy will be terminated. In cases where the lung will not be completely expanded, the control X-ray will be repeated on the 5th, 7th and 10th day of therapy. If, following this, the PNO will persist without resolution, the therapy will be declared non-effective and other therapy modes will be used (conversion to large bore chest drainage in the Pleuralvent™group and surgical treatment in the chest drainage group).
Interventions
DEVICEPleuralvent™
Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)
PROCEDUREChest tube
Chest tube insertion
Sponsors
Thomayer University Hospital
University Hospital Olomouc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Method of closed envelopes
Intervention model description
Randomised, non-blinded, actively controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Iatrogenic pneumothorax indicated for invasive therapy
Exclusion criteria
* Chronic analgesic therapy * Contraindications for Pleuralvent™ use * Non-compliance of patients * Clinically significant hepatopathy (alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 times normal values) * Clinically significant renal insufficiency (glomerular filtration \< 0.5 ml/kg/min) * Allergy to metamizole/tramadol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficiency | up to 10 days of treatment or until the treatment is terminated | Condition with no need for further therapy modes defined as a absence of pneumothorax on chest X-ray |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic use | up to 10 days of treatment or until the treatment is terminated | Comparison of analgesic use in groups - with Pleuralvent™ or large bore chest tube therapy |
| The time to lung re-expansion | up to 10 days of treatment or until the treatment is terminated | The treatment duration needed to lung re-expansion |
| Subjective pain perception according to Visual Analogue Scale (VAS) scale | up to 10 days of treatment or until the treatment is terminated | Subjective pain perception according to Visual Analogue Scale (scale 0-10, where 0 represents no pain and 10 excruciating pain) |
Countries
Czechia
Contacts
Primary ContactMilan Sova, MD, Ph.D.
Outcome results
None listed