Ballooned Intercostal Drain Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial of the Use of a Dedicated Ballooned Intercostal Tube

Conditions
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Pleural Effusion, Pneumothorax

Intervention / Treatment
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* Device: Ballooned intercostal drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >16 years Able to give written informed consent Requiring intercostal tube drainage for clinical reasons Exclusion Criteria: Inability to provide written informed consent Requiring blunt dissection for intercostal tube insertion Haemothorax

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ballooned intercostal drain<br>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. | Device: Ballooned intercostal drain<br>* 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.<br>|
| Active Comparator: Standard intercostal drain<br>Patients will have a standard 12F-16F Rocket Medical chest drain inserted as per usual clinical guidelines, using the Seldinger technique. | Device: Ballooned intercostal drain<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 1 week dependent upon duration of intercostal drainage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in patient reported pain scores, using a visual analogue scale |  | At drain insertion, 24hrs post-insertion, 72hrs-post insertion, and at drain removal, usually a maximum of 7 days | 
| The frequency of balloon rupture |  | Up to 1 week dependent upon duration of intercostal drainage | 
| The difference in duration of drainage between the study arms |  | Up to 1 week dependent upon duration of intercostal drainage | 
| Cost-effectiveness profiles for each intervention |  | Up to 1 week dependent upon duration of intercostal drainage |