Exploring factors influencing patient outcomes in collapsed lung due to underlying lung disease
| ISRCTN | ISRCTN33651795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33651795 |
| IRAS number | 316472 |
| Secondary identifying numbers | CPMS 53700, IRAS 316472 |
- Submission date
- 10/01/2023
- Registration date
- 20/03/2023
- Last edited
- 22/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Secondary spontaneous pneumothorax (SSP) is a medical emergency where an abnormal collection of air develops in the space between the lung and the chest wall, causing lung collapse. This occurs in patients with existing lung diseases such as chronic obstructive pulmonary disease (COPD). In the UK, patients with SSP are usually treated by inserting a drain into the chest to remove the air. The drain is stitched in place and left until the air is completely removed. The drain typically remains in place for over a week, leading to long hospital stays. Sometimes these patients need surgery to help stop the air leaking into the lung, but it is also recognised that these patients may not be fit for major surgery. Unfortunately, we don’t have data from UK patients about the key consequences of developing a secondary spontaneous pneumothorax. For example, we don’t know how long patients stay in hospital, how many go for surgery, and how many develop complications. With this information we can better plan for care, but also look at why some patients stay longer in hospital and why some patients need surgery, whilst others don’t. The aim of this study is to gather information about SSP in an attempt to answer some of these unknown questions. We will recruit patients admitted to hospital with SSP throughout the UK over a period of 1 year. We will collect routine data from the patient’s records, such as age, medical history and how long they stay in the hospital.
Who can participate?
Any patient with a collapsed lung with known or suspected underlying lung disease OR who is over the age of 50 with a significant smoking history is eligible to participate in this study. Patients with a collapsed lung because of an injury or a medical intervention are not eligible.
What does the study involve?
This is an observational study, which means that nothing additional is required from participants outside of their routine care. They will be informed about the study and given the option to decline to participate. The study team will collect data on the patients’ background, their medical history, whether they are or have been a smoker, how fit the patient is and data related to their collapsed lung and how it is managed. Further data will then be collected at 1 month and 6 months post-enrolment. There are no additional interventions required.
What are the possible benefits and risks of participating?
There are no direct clinical benefits to participants from engaging in this research as it is observational. Once the results are published, we hope that the knowledge obtained will benefit patients in the future by helping clinicians understand better how to manage patients with this condition, taking into account different factors that may influence their outcomes. The observational nature of this study means that there are no additional risks to patients from participating.
Where is the study run from?
The lead site is North Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
May 2022 to September 2024
Who is funding the study?
Rocket Medical Plc (UK)
Who is the main contact?
Dr Eleanor Barton, eleanor.barton@nbt.nhs.uk (UK)
Contact information
Scientific
Pleural Clinical Research Fellow
Academic Respiratory Unit
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0003-0381-810X |
|---|---|
| Phone | +44 (0)117 414 8033 |
| eleanor.barton@nbt.nhs.uk |
Study information
| Study design | Multicentre prospective longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| 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 | Longitudinal investigation of secondary pneumothorax |
| Study acronym | LISP |
| Study hypothesis | To determine the characteristics, healthcare burden, management and outcomes of patients with secondary spontaneous pneumothorax in the UK. |
| Ethics approval(s) | Approved 01/12/2022, South West – Frenchay Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8106; frenchay.rec@hra.nhs.uk), ref: 22/SW/0125 |
| Condition | Secondary spontaneous pneumothorax |
| Intervention | Patients presenting with secondary spontaneous pneumothorax (SSP) to any of the hospitals involved in the study will be screened and invited to participate in the study by trained clinicians or research nurses. SSP is defined in this study as a spontaneous pneumothorax with no history of trauma or iatrogenic intervention preceding it in a patient with known or suspected lung disease or a patient over the age of 50 with a smoking history. Patients with SSP will almost exclusively require admission under a specialist respiratory team, and as such we anticipate high patient identification rates. We will collect data on the patient’s demographics, past medical history and history of current illness, smoking status including cannabis, asbestos and other inhalational exposures, clinical frailty score (CFS) and performance status (PS). We will also collect data related to the pneumothorax and its management (e.g. digital or analogue assessment of air leak, size of the pneumothorax on CXR, procedures performed and their outcomes). Further data will be collected from the patient’s medical records at 1 month and 6 months post enrolment, to encompass the patient’s length of stay, number and type of interventions, recurrence, and mortality. These two-time points allow for the collection of complete data sets, acknowledging that some patients may have a prolonged stay exceeding 1 month and ensuring that enough time has elapsed to capture the incidence of recurrence. |
| Intervention type | Other |
| Primary outcome measure | 1. Patient demographics: age (years), gender (M/F), socioeconomic status (Index of multiple deprivations) measured from the patient’s medical records at baseline 2. Number and type of procedures required (number, procedures performed) measured from the patient’s medical records at baseline, 1 month and 6 months 3. Outcomes: Length of stay (days), air leak duration (days), mortality (death rate) measured from the patient’s medical records at baseline, 1 month and 6 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 13/05/2022 |
| Overall study end date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Total final enrolment | 213 |
| Participant inclusion criteria | 1. Emergency attendance to hospital with secondary spontaneous pneumothorax (SSP), confirmed by radiology, with SSP defined as spontaneous pneumothorax in presence of known or suspected lung disease OR spontaneous pneumothorax 2. Aged ≥50 years old 3. History of smoking |
| Participant exclusion criteria | 1. Aged <16 years old 2. Latrogenic pneumothorax 3. Traumatic pneumothorax |
| Recruitment start date | 15/02/2023 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Worthing
BN11 2DH
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Sheffield
S5 7AU
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Pontypridd
CF37 1LB
United Kingdom
Torquay
TQ2 7AA
United Kingdom
London
SE1 7EH
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Worcester
WR5 1DD
United Kingdom
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
North Shields
NE29 8NH
United Kingdom
Wirral
CH49 5PE
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
Floor 3, Learning and Research Centre
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117 4149330 |
|---|---|
| helen.lewis-white@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 28/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a high-impact and peer-reviewed journal 2. Presentation at conferences 3. Information will be accessible via the Academic Respiratory Unit and INSPIRE webpage |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as patients did not consent to this level of data sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 21/12/2022 | 14/01/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
22/04/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The participant level data sharing statement was added.
17/08/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 15/08/2023 to 31/03/2024.
2. The overall study end date was changed from 14/02/2024 to 30/09/2024.
10/01/2023: Trial's existence confirmed by the NIHR.
