Pleural EffusionNCT01869504
A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
A study testing Balloon-tipped intercostal drain in people with Pleural Effusion, run by Sherwood Forest Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Balloon-tipped intercostal drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jun 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >16 years
- Able to give written informed consent
- Requiring intercostal tube drainage of a pleural effusion for clinical reasons
Who cannot join
- Requiring intercostal tube drainage for chest trauma
- Requiring blunt dissection for drain insertion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL
About this study
Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. This often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. One suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. These would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required.
The investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.
- Conditions
- Pleural Effusion
- Being tested
- Balloon-tipped intercostal drain
- Keywords
- Ballooned intercostal drain, Pleural effusion
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-tipped intercostal drainDevice
Also called Manufactured by Rocket Medical.
Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Balloon-tipped intercostal drain | Experimental | Subjects who have given written informed consent and who fulfill the inclusion and exclusion criteria will proceed to have the study drain inserted at the earliest opportunity as per standard hospital protocols using local anaesthetic, and conscious sedation where appropriate. All other aspects of their treatment will be identical to usual clinical care, including chest drain checks and fluid drainage strategies. Receives: Device: Balloon-tipped intercostal drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of intercostal drains requiring re-siting
It is likely that most if not all of the drains will have been removed by this time owing to resolution of the effusion, but the time period of 7 days has been selected to allow maximum data capture.
Measured: 7 days
Secondary outcomes (2)
Patient reported pain scores, using a visual analogue scale
Measured: At 24 hours, 72 hours, and at drain removal, an expected average of 5 days
The frequency of balloon rupture
It is likely that most if not all of the drains will have been removed by this time owing to resolution of the effusion, but the time period of 7 days has been selected to allow maximum data capture.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherwood Forest Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel V Kemp, MBBS, Principal investigator, Sherwood Forest Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869504
- Sponsor's protocol ID
- SFH1
- Status last verified
- May 2017
- First submitted
- 26 Feb 2013
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
- ClinicalTrials.gov ID
- NCT01869504
- Acronym / sponsor ID
- SFH1
- Conditions
- Pleural Effusion
- Keywords
- Ballooned intercostal drain, Pleural effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sherwood Forest Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Jun 2013 (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.
Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. This often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. One suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. These would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required.
The investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon-tipped intercostal drain | Experimental | Device: Balloon-tipped intercostal drainSubjects who have given written informed consent and who fulfill the inclusion and exclusion criteria will proceed to have the study drain inserted at the earliest opportunity as per standard hospital protocols using local anaesthetic, and conscious sedation where appropriate. All other aspects of their treatment will be identical to usual clinical care, including chest drain checks and fluid drainage strategies. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age >16 years
- Able to give written informed consent
- Requiring intercostal tube drainage of a pleural effusion for clinical reasons
Key exclusion criteria (2 listed)
- Requiring intercostal tube drainage for chest trauma
- Requiring blunt dissection for drain insertion
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 |
|---|---|---|
| Balloon-tipped intercostal drainAlso: Manufactured by Rocket Medical.Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance. | Device | Balloon-tipped intercostal drain |
Primary outcome
The percentage of intercostal drains requiring re-siting
Time frame: 7 days
It is likely that most if not all of the drains will have been removed by this time owing to resolution of the effusion, but the time period of 7 days has been selected to allow maximum data capture.
2 secondary outcomes
Patient reported pain scores, using a visual analogue scale
Time frame: At 24 hours, 72 hours, and at drain removal, an expected average of 5 days
The frequency of balloon rupture
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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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 principal investigator
Sherwood Forest Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon-tipped intercostal drain in people with Pleural Effusion, run by Sherwood Forest Hospitals NHS Foundation Trust at 1 site 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 2 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: finished, as of the sponsor's last update on 22 May 2017. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of intercostal drains requiring re-siting (time frame: 7 days). 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 22 May 2017.