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

University Hospital Olomouc

Status: Enrolling

Conditions: Pneumothorax

Treatments: Procedure: Chest tube; Device: Pleuralvent™

Study type: Interventional

Funder types: Other

Identifiers

NCT03700554

ASPIRATE

Details and patient eligibility

About

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).

Full 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).

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

126 participants in 2 patient groups

Pleuralvent™

Experimental group

Description:

Patients treated with Pleuralvent™ device

Treatment:

Device: Pleuralvent™

Chest tube

Active Comparator group

Description:

Patients treated with Chest tube

Treatment:

Procedure: Chest tube