PneumothoraxNCT03034421
Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
A study testing Bed rest in people with Pneumothorax, run by Heidelberg University at 1 site in Germany.
Trial summary
Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Bed rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to 30 Sep 2018
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1 < 50%, RV>150%, TLC>100%
- emphysema confirmed by computed tomography
- pO2 >60 mmHg (with supplemental oxygen), pCO2 < 55 mmHg (room condition)
- no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
- no COPD exacerbation within the past 8 weeks
- daily use of < 20 mg Prednisolon
- non-smoking for a minimum of 4 months prior to consent
- Patient has provided written informed consent
Who cannot join
- BMI < 18 kg/m²
- clinically relevant bronchiectasis
- failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
- Prior lung resection (e.g. lobectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.
Read the detailed description
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.
- Conditions
- Pneumothorax
- Being tested
- Bed rest
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restBehavioural
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.
| Study group | Role | What they receive |
|---|---|---|
| Modified medical care | Active comparator | Patients will undergo 48-hours bed rest after endoscopic valve implantation. Receives: Behavioral: Bed rest |
| Standard medical care | No intervention | Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advent of pneumothorax within 90 days following valve implantation
Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.
Measured: 90 days following valve implantation
Secondary outcomes (3)
Lung function before and after valve therapy
Lung function parameters (VC [L], FEV1 [L], RV [L], TLC [L] will be assessed 30 and 90 days following valve implantation.
Measured: 30 and 90 days following valve implantation
Excercise capacity before and after valve therapy
6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.
Measured: 30 and 90 days following valve implantation
Dyspnoe score before and after valve therapy
Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.
Measured: 30 and 90 days following valve implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startSep 2016
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
Why it stopped: difficult patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Daniela Gompelmann, MD, Principal investigator, Thoraxklinik at University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034421
- Sponsor's protocol ID
- Protocol G1.1 - 17.04.2016
- Status last verified
- Jul 2022
- First submitted
- 16 Sep 2016
- Last updated
- 7 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
- ClinicalTrials.gov ID
- NCT03034421
- Acronym / sponsor ID
- Protocol G1.1 - 17.04.2016
- Conditions
- Pneumothorax
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult patient recruitment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.
Detailed description
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified medical care | Active comparator | Behavioral: Bed restPatients will undergo 48-hours bed rest after endoscopic valve implantation. |
| Standard medical care | No intervention | –Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- FEV1 < 50%, RV>150%, TLC>100%
- emphysema confirmed by computed tomography
- pO2 >60 mmHg (with supplemental oxygen), pCO2 < 55 mmHg (room condition)
- no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
- no COPD exacerbation within the past 8 weeks
Key exclusion criteria (4 listed)
- BMI < 18 kg/m²
- clinically relevant bronchiectasis
- failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
- Prior lung resection (e.g. lobectomy)
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 |
|---|---|---|
| Bed restPatients will undergo bed rest for 48 hours following endoscopic valve implantation. | Behavioural | Modified medical care |
Primary outcome
Advent of pneumothorax within 90 days following valve implantation
Time frame: 90 days following valve implantation
Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.
3 secondary outcomes
Lung function before and after valve therapy
Time frame: 30 and 90 days following valve implantation
Excercise capacity before and after valve therapy
Time frame: 30 and 90 days following valve implantation
Dyspnoe score before and after valve therapy
Time frame: 30 and 90 days following valve implantation
Results and safety
The study was stopped early (reason given: difficult patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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.
Daniela Gompelmann, MD principal investigator
Thoraxklinik at University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest in people with Pneumothorax, run by Heidelberg University at 1 site in Germany.
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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Jul 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 Germany. 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?
The study was stopped early (reason given: difficult patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advent of pneumothorax within 90 days following valve implantation (time frame: 90 days following valve implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2022.