PneumothoraxASPIRATENCT03700554
Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Chest Tube
A study testing Pleuralvent™ and Chest tube in people with Pneumothorax, run by University Hospital Olomouc at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Pleuralvent™ and Chest tube
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Feb 2019to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Iatrogenic pneumothorax indicated for invasive therapy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc
Milan Sova, MD.,
About this study
Official title: ASPIRATE Study- Comparison of Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Large Bore Chest Tube (16F)
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).
Read the 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).
- Conditions
- Pneumothorax
- Being tested
- Pleuralvent™, Chest tube
- Keywords
- Pneumothorax, Iatrogenic, Chest tube, Pleuralvent
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleuralvent™Device
Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)
Chest tubeProcedure or surgery
Chest tube insertion
| Study group | Role | What they receive |
|---|---|---|
| Pleuralvent™ | Experimental | Patients treated with Pleuralvent™ device Receives: Device: Pleuralvent™ |
| Chest tube | Active comparator | Patients treated with Chest tube Receives: Procedure: Chest tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficiency
Condition with no need for further therapy modes defined as a absence of pneumothorax on chest X-ray
Measured: up to 10 days of treatment or until the treatment is terminated
Secondary outcomes (3)
Analgesic use
Comparison of analgesic use in groups - with Pleuralvent™ or large bore chest tube therapy
Measured: up to 10 days of treatment or until the treatment is terminated
The time to lung re-expansion
The treatment duration needed to lung re-expansion
Measured: up to 10 days of treatment or until the treatment is terminated
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)
Measured: up to 10 days of treatment or until the treatment is terminated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start3 Feb 2019
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, non-blinded, actively controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Thomayer University Hospital
- Responsible party
- Principal investigator, Milan Sova, University Hospital Olomouc
- Investigators
- Milan Sova, MD, Ph.D., Principal investigator, Department of Pulmonary Diseases and Tuberculosis Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital, Olomouc, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700554
- Sponsor's protocol ID
- ASPIRATE
- Acronym
- ASPIRATE
- Status last verified
- Nov 2022
- First submitted
- 1 Oct 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available upon legitimate request.
Publications
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.
PubMed 20696690Horsley 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.
PubMed 17167009Funaki 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.
PubMed 21326805Vedam 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.
PubMed 14656251Akowuah 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.
PubMed 12407390Bhatnagar 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.
PubMed 27246597Sova 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.
PubMed 32153301
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRATE Study- Comparison of Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Large Bore Chest Tube (16F)
- ClinicalTrials.gov ID
- NCT03700554
- Acronym / sponsor ID
- ASPIRATE / ASPIRATE
- Conditions
- Pneumothorax
- Keywords
- Pneumothorax, Iatrogenic, Chest tube, Pleuralvent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Thomayer University Hospital
- Study start
- 3 Feb 2019 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised, non-blinded, actively controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Pleuralvent™ | Experimental | Device: Pleuralvent™Patients treated with Pleuralvent™ device |
| Chest tube | Active comparator | Procedure: Chest tubePatients treated with Chest tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Iatrogenic pneumothorax indicated for invasive therapy
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleuralvent™Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device) | Device | Pleuralvent™ |
| Chest tubeChest tube insertion | Procedure or surgery | Chest tube |
Primary outcome
Treatment efficiency
Time frame: up to 10 days of treatment or until the treatment is terminated
Condition with no need for further therapy modes defined as a absence of pneumothorax on chest X-ray
3 secondary outcomes
Analgesic use
Time frame: up to 10 days of treatment or until the treatment is terminated
The time to lung re-expansion
Time frame: up to 10 days of treatment or until the treatment is terminated
Subjective pain perception according to Visual Analogue Scale (VAS) scale
Time frame: up to 10 days of treatment or until the treatment is terminated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 20696690MacDuff 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.
- Background: PubMed 17167009Horsley 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.
- Background: PubMed 21326805Funaki 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.
- Background: PubMed 14656251Vedam 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.
- Background: PubMed 12407390Akowuah 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.
- Background: PubMed 27246597Bhatnagar 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.
- Derived from this study: PubMed 32153301Sova 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.
- Individual participant dataSharing planned: Yes. Raw data will be available upon legitimate request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Sova, MD, Ph.D. principal investigator
Department of Pulmonary Diseases and Tuberculosis Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital, Olomouc, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleuralvent™ and Chest tube in people with Pneumothorax, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milan Sova, MD, Ph.D. (+420588445326, milan.sova@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficiency (time frame: up to 10 days of treatment or until the treatment is terminated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700554, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.