Pleural EffusionNCT03000504
Ballooned Intercostal Drain Trial
A study testing Ballooned intercostal drain in people with Pleural Effusion and Pneumothorax, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
This study is designed to assess whether a new type of chest drain reduces the number of drains that fall out of or are accidentally removed from the chest cavity (usually requiring another drain to be inserted), without causing any increase in discomfort or other side-effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pneumothorax
- What is being tested?
- Ballooned intercostal drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 7 Mar 2018to Jul 2019
- 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
- Age >16 years
- Able to give written informed consent
- Requiring intercostal tube drainage for clinical reasons
Who cannot join
- Inability to provide written informed consent
- Requiring blunt dissection for intercostal tube insertion
- Haemothorax
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Samuel V Kemp, MBBS MD, +442073518021, s.kemp@rbht.nhs.uk
- Recruiting
Oxford Respiratory Trials Unit
Oxford, Oxfordshire, OX3 7LE
Najib Rahman, PhD, +441865 225256, najib.rahman@ndm.ox.ac.uk
- Recruiting
Sherwood Forest Hospitals NHS Foundation Trusty
Sutton in Ashfield, Nottinghamshire, NG17 4JL
Nicola J Downer, MBBS, +441623622515, nicola.downer@sfh-tr.nhs.uk
About this study
Official title: A Randomized, Controlled Trial of the Use of a Dedicated Ballooned Intercostal Tube
This study is designed to assess whether a new type of chest drain reduces the number of drains that fall out of or are accidentally removed from the chest cavity (usually requiring another drain to be inserted), without causing any increase in discomfort or other side-effects.
Read the detailed description
Chest drains are an essential part of the treatment for patients with fluid or air around the lung, which usually causes breathlessness. Draining the fluid or air relieves symptoms and allows investigations to be carried out that can identify a cause for why the fluid or air is there. Chest drains are difficult to secure in place, and sometimes fall out despite the best possible care. This study tests a modified drain that has a small balloon near the end which, when inflated inside the chest cavity, should make it much harder for the drain to fall out of the chest. This was tested in a small pilot study, with encouraging results. The current study is comparing a group of patients treated with the new ballooned drain against a group treated with the standard drain, with patients equally but randomly allocated to each group. The chest drain has been through rigorous laboratory testing and has been CE marked for human use.
All patients requiring intercostal drainage for clinical reasons will be offered entry into the study, unless, in the view of the treating physician, blunt dissection is required. No other screening assessments will be required, other than the ability to sign the informed consent form.Patients who have provided signed informed consent will then proceed to the study protocol. Patients will be randomised to undergo either standard ICT insertion (usual clinical care) or insertion of the study drain using standard clinical policies and procedures at each participating centre.
Once a patient has been identified for the trial and has signed the informed consent form, baseline details will be entered into a dedicated web-based programme accessible at all sites, and patients will be allocated 1:1 to either usual care or to the study drain.
All subsequent care will be as per best clinical care for all patients in both arms of the study. The only additional assessments over and above usual care will be the collection of pain scores. Pain will be rated by the patients on a visual analogue scale (VAS) on up to 4 occasions - insertion, 24 and 72 hours post insertion, and at drain removal.
- Conditions
- Pleural Effusion, Pneumothorax
- Being tested
- Ballooned intercostal drain
- Medical subject headings
- Pleural Effusion, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballooned intercostal drainDevice
Patients will have a Rocket Medical 16F ballooned intercostal drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.
| Study group | Role | What they receive |
|---|---|---|
| Ballooned intercostal drain | Experimental | Patients will have a Rocket Medical 16F ballooned chest drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique. Receives: Device: Ballooned intercostal drain |
| Standard intercostal drain | Active comparator | Patients will have a standard 12F-16F Rocket Medical chest drain inserted as per usual clinical guidelines, using the Seldinger technique. Receives: Device: Ballooned intercostal drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the percentage of accidental removal of ICTs between study arms
The number of drains prematurely and unintentionally removed from the pleural space
Measured: Up to 1 week dependent upon duration of intercostal drainage
Secondary outcomes (4)
The difference in patient reported pain scores, using a visual analogue scale
Measured: At drain insertion, 24hrs post-insertion, 72hrs-post insertion, and at drain removal, usually a maximum of 7 days
The frequency of balloon rupture
Measured: Up to 1 week dependent upon duration of intercostal drainage
The difference in duration of drainage between the study arms
Measured: Up to 1 week dependent upon duration of intercostal drainage
Cost-effectiveness profiles for each intervention
Measured: Up to 1 week dependent upon duration of intercostal drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start7 Mar 2018
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies 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
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sherwood Forest Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Samuel V Kemp, MBBS, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000504
- Sponsor's protocol ID
- 217496
- Status last verified
- May 2018
- First submitted
- 25 Nov 2016
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of the Use of a Dedicated Ballooned Intercostal Tube
- ClinicalTrials.gov ID
- NCT03000504
- Acronym / sponsor ID
- 217496
- Conditions
- Pleural Effusion, Pneumothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sherwood Forest Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 22 Dec 2016 (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.
This study is designed to assess whether a new type of chest drain reduces the number of drains that fall out of or are accidentally removed from the chest cavity (usually requiring another drain to be inserted), without causing any increase in discomfort or other side-effects.
Detailed description
Chest drains are an essential part of the treatment for patients with fluid or air around the lung, which usually causes breathlessness. Draining the fluid or air relieves symptoms and allows investigations to be carried out that can identify a cause for why the fluid or air is there. Chest drains are difficult to secure in place, and sometimes fall out despite the best possible care. This study tests a modified drain that has a small balloon near the end which, when inflated inside the chest cavity, should make it much harder for the drain to fall out of the chest. This was tested in a small pilot study, with encouraging results. The current study is comparing a group of patients treated with the new ballooned drain against a group treated with the standard drain, with patients equally but randomly allocated to each group. The chest drain has been through rigorous laboratory testing and has been CE marked for human use.
All patients requiring intercostal drainage for clinical reasons will be offered entry into the study, unless, in the view of the treating physician, blunt dissection is required. No other screening assessments will be required, other than the ability to sign the informed consent form.Patients who have provided signed informed consent will then proceed to the study protocol. Patients will be randomised to undergo either standard ICT insertion (usual clinical care) or insertion of the study drain using standard clinical policies and procedures at each participating centre.
Once a patient has been identified for the trial and has signed the informed consent form, baseline details will be entered into a dedicated web-based programme accessible at all sites, and patients will be allocated 1:1 to either usual care or to the study drain.
All subsequent care will be as per best clinical care for all patients in both arms of the study. The only additional assessments over and above usual care will be the collection of pain scores. Pain will be rated by the patients on a visual analogue scale (VAS) on up to 4 occasions - insertion, 24 and 72 hours post insertion, and at drain removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ballooned intercostal drain | Experimental | Device: Ballooned intercostal drainPatients will have a Rocket Medical 16F ballooned chest drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique. |
| Standard intercostal drain | Active comparator | Device: Ballooned intercostal drainPatients will have a standard 12F-16F Rocket Medical chest drain inserted as per usual clinical guidelines, using the Seldinger technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >16 years
- Able to give written informed consent
- Requiring intercostal tube drainage for clinical reasons
Key exclusion criteria (3 listed)
- Inability to provide written informed consent
- Requiring blunt dissection for intercostal tube insertion
- Haemothorax
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 |
|---|---|---|
| Ballooned intercostal drainPatients will have a Rocket Medical 16F ballooned intercostal drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique. | Device | Ballooned intercostal drain, Standard intercostal drain |
Primary outcome
The difference in the percentage of accidental removal of ICTs between study arms
Time frame: Up to 1 week dependent upon duration of intercostal drainage
The number of drains prematurely and unintentionally removed from the pleural space
4 secondary outcomes
The difference in patient reported pain scores, using a visual analogue scale
Time frame: At drain insertion, 24hrs post-insertion, 72hrs-post insertion, and at drain removal, usually a maximum of 7 days
The frequency of balloon rupture
Time frame: Up to 1 week dependent upon duration of intercostal drainage
The difference in duration of drainage between the study arms
Time frame: Up to 1 week dependent upon duration of intercostal drainage
Cost-effectiveness profiles for each intervention
Time frame: Up to 1 week dependent upon duration of intercostal drainage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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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.
Samuel V Kemp, MBBS, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballooned intercostal drain in people with Pleural Effusion and Pneumothorax, run by Royal Brompton & Harefield NHS Foundation Trust at 3 sites in United Kingdom.
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 3 inclusion and 3 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 Samuel V Kemp, MBBS, MD (+442073518021, s.kemp@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the percentage of accidental removal of ICTs between study arms (time frame: Up to 1 week dependent upon duration of intercostal drainage). 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 16 May 2018.