Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Chest Tube
NCT ID: NCT03700554
Last Updated: 2022-11-02
Study Results
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Basic Information
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UNKNOWN
NA
126 participants
INTERVENTIONAL
2019-02-03
2024-11-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pleuralvent™
Patients treated with Pleuralvent™ device
Pleuralvent™
Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)
Chest tube
Patients treated with Chest tube
Chest tube
Chest tube insertion
Interventions
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Pleuralvent™
Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)
Chest tube
Chest tube insertion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Thomayer University Hospital
OTHER
University Hospital Olomouc
OTHER
Responsible Party
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Milan Sova
MD, Ph.D.
Principal Investigators
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Milan Sova, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Pulmonary Diseases and Tuberculosis Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital, Olomouc, Czech Republic
Locations
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University Hospital Olomouc
Olomouc, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Milan Sova, MD.,
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ASPIRATE
Identifier Type: -
Identifier Source: org_study_id
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