Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Chest Tube

Study Overview
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Brief Summary
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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
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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).

Official Title
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ASPIRATE Study- Comparison of Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Large Bore Chest Tube (16F)

Conditions
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Pneumothorax

Intervention / Treatment
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* Device: Pleuralvent™
* Procedure: Chest tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, non-blinded, actively controlled clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pleuralvent™<br>Patients treated with Pleuralvent™ device | Device: Pleuralvent™<br>* Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)<br>|
| Active Comparator: Chest tube<br>Patients treated with Chest tube | Procedure: Chest tube<br>* Chest tube insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficiency | Condition with no need for further therapy modes defined as a absence of pneumothorax on chest X-ray | up to 10 days of treatment or until the treatment is terminated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic use | Comparison of analgesic use in groups - with Pleuralvent™ or large bore chest tube therapy | up to 10 days of treatment or until the treatment is terminated | 
| The time to lung re-expansion | The treatment duration needed to lung re-expansion | up to 10 days of treatment or until the treatment is terminated | 
| Subjective pain perception according to Visual Analogue Scale (VAS) scale | Subjective pain perception according to Visual Analogue Scale (scale 0-10, where 0 represents no pain and 10 excruciating pain) | up to 10 days of treatment or until the treatment is terminated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumothorax, Iatrogenic, Chest tube, Pleuralvent