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

NCT03700554 | Unknown

• 1 other identifier: ASPIRATE
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumothorax

Keywords

Pneumothorax; Iatrogenic; Chest tube; Pleuralvent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Analgesic use

  up to 10 days of treatment or until the treatment is terminated

• The time 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

  up to 10 days of treatment or until the treatment is terminated

Study Arms (2)

Pleuralvent™

EXPERIMENTAL

Patients treated with Pleuralvent™ device

Device: Pleuralvent™

Chest tube

ACTIVE COMPARATOR

Patients treated with Chest tube

Procedure: Chest tube

Interventions

Pleuralvent™ DEVICE

Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)

Pleuralvent™

Chest tube PROCEDURE

Chest tube insertion

Chest tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Iatrogenic pneumothorax indicated for invasive therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Thomayer University Hospital: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

Related Publications (7)

• 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.

  PMID: 20696690 BACKGROUND

• 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.

  PMID: 17167009 BACKGROUND

• 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.

  PMID: 21326805 BACKGROUND

• 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.

  PMID: 14656251 BACKGROUND

• 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.

  PMID: 12407390 BACKGROUND

• 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.

  PMID: 27246597 BACKGROUND

• 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.

  PMID: 32153301 DERIVED

MeSH Terms

Conditions

Pneumothorax

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Milan Sova, MD, Ph.D.

  Department of Pulmonary Diseases and Tuberculosis Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital, Olomouc, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milan Sova, MD, Ph.D.

CONTACT

+420588445326; milan.sova@fnol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Method of closed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.

Model Details: Randomised, non-blinded, actively controlled clinical trial.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 9, 2018
• Study Start: February 3, 2019
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available after completion of the study
• Access Criteria: Upon request

Locations

CZ (1)