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

Pneumothorax Clinical Trial

— ASPIRATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700554
• Other study ID #: ASPIRATE
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2019
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2022
• Source: University Hospital Olomouc
• Contact: Milan Sova, MD, Ph.D.
• Phone: +420588445326
• Email: milan.sova[@]fnol.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Device:
• Pleuralvent™
Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)

Procedure:
• Chest tube
Chest tube insertion

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Thomayer University Hospital

Country where clinical trial is conducted

Czechia, 

References & Publications (6)

Akowuah E, Ho EC, George R, Brennan K, Tennant S, Braidley P, Cooper G. Less pain with flexible fluted silicone chest drains than with conventional rigid chest tubes after cardiac surgery. J Thorac Cardiovasc Surg. 2002 Nov;124(5):1027-8. — View Citation

Bhatnagar R, Corcoran JP, Maldonado F, Feller-Kopman D, Janssen J, Astoul P, Rahman NM. Advanced medical interventions in pleural disease. Eur Respir Rev. 2016 Jun;25(140):199-213. doi: 10.1183/16000617.0020-2016. Review. — View Citation

Funaki B. Pneumothorax treated by small-bore chest tube. Semin Intervent Radiol. 2007 Jun;24(2):272-6. doi: 10.1055/s-2007-980051. — View Citation

Horsley A, Jones L, White J, Henry M. Efficacy and complications of small-bore, wire-guided chest drains. Chest. 2006 Dec;130(6):1857-63. — View Citation

MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. — View Citation

Vedam H, Barnes DJ. Comparison of large- and small-bore intercostal catheters in the management of spontaneous pneumothorax. Intern Med J. 2003 Nov;33(11):495-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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