Clinical trial NCT03700554: Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Chest Tube
Official title: ASPIRATE Study- Comparison of Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Large Bore Chest Tube (16F)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumothorax
Keywords: Pneumothorax
Iatrogenic
Chest tube
Pleuralvent
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Thomayer University Hospital
First posted: 2018-10-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, non-blinded, actively controlled clinical trial.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Treatment efficiency
timeFrame: up to 10 days of treatment or until the treatment is terminated
Secondary outcomes:
measure: Analgesic use
timeFrame: up to 10 days of treatment or until the treatment is terminated
measure: The time to lung re-expansion
timeFrame: up to 10 days of treatment or until the treatment is terminated
measure: Subjective pain perception according to Visual Analogue Scale (VAS) scale
timeFrame: up to 10 days of treatment or until the treatment is terminated
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: Department of Pulmonary Diseases and Tuberculosis Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital, Olomouc, Czech Republic
name: Milan Sova, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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. doi: 10.1378/chest.130.6.1857.
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. No abstract available.
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. doi: 10.1046/j.1445-5994.2003.00467.x.
citation: 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. doi: 10.1067/mtc.2002.125641. No abstract available.
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.
citation: Sova M, Poruba M, Genzor S, Jakubec P, Zatloukal J, Kolek V, Urbanek K, Vasakova M, Stehlik L, Zackova P, Asswad AG. Efficacy and analgesic use during the therapy of iatrogenic pneumothorax using Pleuralvent and Chest Tube (ASPIRATE): A randomised controlled trial protocol. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Jun;164(2):213-215. doi: 10.5507/bp.2020.008. Epub 2020 Mar 9.