The use of an ambulatory device in treatment of pneumothoraces caused by underlying lung disease
| ISRCTN | ISRCTN79956557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79956557 |
| Secondary identifying numbers | 31533 |
- Submission date
- 24/10/2016
- Registration date
- 24/10/2016
- Last edited
- 06/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
A pneumothorax is a collection of air around the lung within the chest which can be due to an injury puncturing the lung or due to a leak of air from the lung. A leak of air from the lung can occur spontaneously in patients who have no lung disease (primary spontaneous pneumothorax) or in patients who have lung disease (secondary spontaneous pneumothorax). This causes the lung to collapse, leading to breathlessness and often chest pain. The treatment of a pneumothorax often involves a tube being inserted into the space around the lung to allow the air to escape and the lung to inflate again. The tube inserted in the space around the lung is usually connected to an ‘underwater seal’ with the tip of the tube left in a bottle of sterile water. This allows air to escape from the chest by bubbling through the water, whilst stopping it from being drawn back into the chest through the tube. This set up means that patients have to carry around a bottle of water with them and can sometimes lead to patients not being as mobile as they could be. Another device which can be used to allow air to escape from the lung but not to re-enter is a Heimlich valve, which is an enclosed plastic valve connected to a chest tube. Studies have shown that Heimlich valves can be useful for the treatment of pneumothorax and may allow patients to be treated at home. For patients with lung disease and secondary spontaneous pneumothorax there are studies suggesting that these valves are safe and have some advantages, but there are no studies directly comparing them against a normal underwater seal. The aim of this study is to find out whether there are any advantages or disadvantages of Heimlich valves compared with underwater seals in patients with secondary spontaneous pneumothorax.
Who can participate?
Patients aged over 18 with secondary spontaneous pneumothorax who require a chest drain
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual treatment with an underwater seal. This involves having a chest tubes (drains) placed into the space around the deflated lung, which are connected to an underwater seal drainage system. Those in the second group are treated using a Heimlich valve. This involves having a chest tube placed into the space around the lung with a one-way valve to stop air coming into the chest through the tube when the patient breathes in. The tube and valve may be attached to a plastic bag to collect fluid. Patients in both groups are followed up for 26 weeks. The study looks at how long patients are in hospital for and will also look at patients’ quality of life, the amount of chest pain and breathlessness they have, how many other procedures they might require for treatment of their pneumothorax and when these other procedures are required, and how many go on to require surgery for their pneumothorax or are readmitted to hospital. The study also assesses whether this treatment affects pneumothorax happening again, or any problems related to the procedures.
What are the possible benefits and risks of participating?
It is hoped that all patients will benefit from the lung re-expanding whether it is with a standard chest drain or with a Heimlich valve. There are a few risks with both procedures, such as introducing infection or causing bleeding, but it is not known which treatment is safer or more effective. Both treatments will involve a stay in hospital. Chest X-rays are used for the investigation and monitoring of pneumothorax and will be required whether or not patients take part in the study. The study requires patients to have three chest X-rays, two of which are additional to standard care, one at each of the follow-up visits. There is a small theoretical risk with this extra radiation, but chest x-rays are associated with a low level of radiation. Three X-rays are equivalent to two weeks of background radiation in the UK.
Where is the study run from?
Southmead Hospital and five other NHS hospitals in England (UK)
When is the study starting and how long is it expected to run for?
January 2016 to April 2019
Who is funding the study?
Rocket Medical PLD (UK)
Who is the main contact?
Dr Steven Walker
steven.walker@nbt.nhs.uk
Contact information
Scientific
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB ·
United Kingdom
| Phone | +44 117 414 8040 |
|---|---|
| steven.walker@nbt.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Heimlich valves in secondary spontaneous pneumothorax: Enhancing Care (Hi-SPEC) |
| Study hypothesis | The aim of this study is to evaluate the effect of Heimlich valves on length of stay in patients admitted to hospital with secondary spontaneous pneumothorax. |
| Ethics approval(s) | South West - Exeter Research Ethics Committee, 14/03/2016, ref: 16/SW/0023 |
| Condition | Pneumothorax |
| Intervention | Patients are randomised to treatment with either a seldinger chest drain or to treatment with a Rocket Pleural Vent in a 1:1 ratio through a randomisation server in random permuted blocks. Control group: Participants receive treatment with a seldinger chest drain and underwater seal. The procedure for seldinger insertion involves: 1. Positioning the patient comfortably in a semi-recumbent postiion 2. Preparing the sterile area and equipment 3. Cleaning insertion site, using drapes to maintain sterility 4. Administering appropriate and adequate local anaesthetic to insertion site: subcutaneously with orange needle then infiltrating to the pleura with green needle (if required) until air is aspirated 5. Making a small (4-5mm) incision in the skin using the scalpel 6. Inserting the introducer needle until air aspirated 7. Threading the guide wire through introducer needle 8. Removing the introducer needle, leaving guide wire in place 9. Dilating the tract with the dilator thread over the guide wire 10. Feeding the chest drain (12-14g) over the guide wire and removing the wire 11. Connecting the 3-way tap to end of drain in the "off" position 12. Suturing the drain in place and placing an adhesive dressing ("drainfix" or equivalent) 13. Having the assistant prepare the chest drain bottle with 500ml of sterile water (filled to "prefill" line) 14. Inserting connection tubing to chest drain bottle and passing the sterile end to sterile operator to connect to chest drain 15. Opening the 3-way tap and checking flow of air (“bubbling and swinging” through chest drain bottle) Intervention group: Participants receive treatment with a Rocket Pleural Vent. The procedure for pleural vent insertion includes: 1. Positioning the patient comfortably in a semi-recumbent postiion 2. Preparing the sterile area and equipment 3. Cleaning insertion site, using drapes to maintain sterility 4. Administering appropriate and adequate local anaesthetic to insertion site: subcutaneously with orange needle then infiltrating to the pleura with green needle (if required) until air is aspirated 5. Making a small (4-5mm) incision in the skin using the scalpel 6. Removing the protection sheath from the catheter and slowly inserting the device needle through the skin incision over the superior border of the rib into the pleural space 7. Attaching the syringe and aspirating air to confirm position 8. Once position is confirmed, removing the needle and syringe from the one-way valve by rotating the connection cap anti-clockwise, slowly advancing the catheter into the pleural space whilst removing the needle (leaving only the pigtail catheter in the chest) 9. Once needle is fully removed, securing the catheter to the skin surface using the attached dressings 10. Attaching the valve cap Following insertion of a Rocket Pleural Vent or a standard chest drain, patients’ care will proceed according to standard care guided by the treating clinician. Decisions regarding removal of the chest drains or Pleural Vent will be made by the treating clinician in reference to BTS guidance and standard local practice. Chest drains or Pleural Vents should be removed at the earliest opportunity following clarifying the absence of an ongoing air leak. VAS scores for pain and breathlessness will be collected on a daily basis for 4 weeks after randomisation and quality of life data will be collected on a daily basis for the first 14 days after randomisation. Participants will be asked to attend a week 4 and week 12 visit. At this visit they will have a clinical assessment, asked to complete a quality of life questionnaire and have a chest x-ray performed. At week 12 they will also have spirometry. At week 26 they will receive a telephone call asking if they have had recurrence of their pneumothorax. |
| Intervention type | Other |
| Primary outcome measure | Length of hospital admission is measured in days by medical record review at the 4 and 12 week visit. |
| Secondary outcome measures | 1. Breathlessness is assessed using a visual analogue scale (VAS) daily over the first 28 days after randomisation 2. Chest pain is assessed using a visual analogue scale (VAS) daily over the first 28 days after randomisation 3. Quality of life measured using the EQ-5D-5L questionnaire daily over first 14 days after randomisation 4. Number of procedures required for management (including pleural aspirations, chest drain insertion, pleurodesis attempts, thoracic surgical intervention) are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits. 5. Time to drain removal is measured in days from randomisation are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits 6. Time to further intervention is measured by in days from randomisation are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits. 7. Surgical intervention for pneumothorax is measured in days from randomisation are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits and 26 weeks phone call. 8. Adverse event rate is measured by patient interview and medical record review at the 4 and 12 visits and 26 weeks phone call. 9. Recurrent pneumothorax is assessed by recording the occurrence of ipsilateral recurrent pneumothorax at end of 26 weeks follow up by patient interview and medical record review |
| Overall study start date | 01/09/2015 |
| Overall study end date | 01/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 66; UK Sample Size: 66 |
| Total final enrolment | 41 |
| Participant inclusion criteria | 1. New diagnosis of a secondary spontaneous pneumothorax as confirmed by a chest radiograph or CT scan 2. Secondary spontaneous pneumothorax defined by known underlying lung disease or a patient > 50 years old with a significant smoking history (>20 pack years) 3. Chest drain insertion indicated for treatment of pneumothorax according to current BTS guidelines 4. Chest drain insertion possible at both 2nd intercostal space |
| Participant exclusion criteria | 1. Current iatrogenic or traumatic pneumothorax 2. Drain already in place for pneumothorax 3. Previous history of tension pneumothorax 4. Features of tension pneumothorax associated with current presentation 5. Evidence of hydropneumothorax or haemopneumothorax 6. Age <18 years 7. Patients bed-bound prior to pneumothorax 8. Contraindication to either chest drain insertion or rocket pleural vent insertion 9. Females who are pregnant or lactating 10. Patients with no access to a telephone 11. Inability to comply with trial requirements or provide informed consent |
| Recruitment start date | 01/11/2016 |
| Recruitment end date | 01/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Oxford
OX3 9DU
United Kingdom
Stoke-on-Trent
ST4 7LN
United Kingdom
Taunton
TA1 5DA
United Kingdom
Swindon
SN3 6BB
United Kingdom
London
SE1 9RT
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 117 414 8114 |
|---|---|
| ResearchSponsor@nbt.nhs.uk | |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Both the trial protocol and trial results will be published in a peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are available from Dr Emma Keenan (Emma.Keenan@nbt.nhs.uk) on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/06/2021 | 06/07/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/07/2021: Publication reference and total final enrolment added.
28/03/2019: The condition has been changed from "Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of pleura" to "Pneumothorax" following a request from the NIHR.
22/01/2019: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 01/11/2018 to 01/06/2019
2. The overall trial end date has been changed from 02/05/2019 to 01/12/2019
3. The intention to publish date has been changed from 01/04/2020 to 01/12/2020
27/10/2016: Verified study information with principal investigator.
