Condition category
Respiratory
Date applied
26/06/2017
Date assigned
03/07/2017
Last edited
03/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A pleural effusion is a collection of fluid between the lung and the chest wall. It commonly occurs as a result of pneumonia and can cause significant breathlessness. In about 10% of cases, this fluid can itself go on to become infected, which increases the chances of someone becoming unwell enough to need surgery, or even dying. It is important that the fluid is drained away completely soon after someone is diagnosed with pleural infection. This is usually done by inserting a small chest tube between the ribs and allowing the fluid to drain out over time. This treatment typically requires many days in hospital but is generally low risk. Medical thoracoscopy is a common technique used to diagnose and drain effusions, although it is not routinely used for pleural infection in the UK as it tends to be reserved for those who are suspected of having cancer. It involves inserting a small camera between the ribs into the fluid and can be done under local anaesthetic. The procedure is very safe but carries a slightly higher risk of complications than standard chest tube insertion. However, the main benefit of the procedure is that it can allow a patient to spend less time in hospital because the chest is drained completely all at once. The aim of this study is to evaluate whether hospitals are able to safely offer medical thoracoscopy to patients with pleural infection

Who can participate?
Adults aged 18 and older who have pleural effusion.

What does the study involve?
Eligible participants are asked to answer questions about their background and previous health. Participants are randomly allocated to one of two groups that determined how their infected fluid is drained. Those in the first group receive the standard treatment, whereby a small tube is inserted between the ribs under local anaesthetic and the fluid is drained. Those in the second group receive the study treatment, which involves placing a small camera between the ribs to inspect and drain the fluid away. Participants are discharged after a few days in hospital. During their stay, participants receive standard care and treatment, but are also asked to perform simple breathing tests and answer some questions about their symptoms and quality of life. Participants are followed up at their local hospital by the trial team after one month and three months, when further information about their recovery and symptoms is gathered to see how the treatment affects patients themselves, and whether it is effective at reducing patients’ time in hospital or their need for surgery. About half of the patients enrolled will also be invited to take part in a more in-depth interview about their experiences in the trial.

What are the possible benefits and risks of participating?
There are no notable benefits with participating however participants are reimbursed for travel expenses. There are no notable risks however, there is normally some risk associated with any medical procedure and this will be discussed in detail with participants depending which treatment they are asked to undergo.

Where is the study run from?
This study takes place at the Southmead Hospital (UK) and takes place in seven other hospitals in the UK.

When is the study starting and how long is it expected to run for?
July 2016 to July 2018

Who is funding the study?
Academy of Medical Sciences (UK)

Who is the main contact?
1. Dr Rahul Bhatnagar
rbhatnagar@doctors.org.uk
2. Dr Emma Keenan
Emma.Keenan@nbt.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Rahul Bhatnagar

ORCID ID

http://orcid.org/0000-0003-3906-1997

Contact details

Academic Respiratory Unit
Learning and Research Building
Level 2
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 7887 997420
rbhatnagar@doctors.org.uk

Type

Public

Additional contact

Dr Emma Keenan

ORCID ID

Contact details

Respiratory Research Unit
Clinical Research Centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 117 414 8114
Emma.Keenan@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33928

Study information

Scientific title

Studying Pleuroscopy in Routine Pleural Infection Treatment Trial

Acronym

SPIRIT

Study hypothesis

Randomising patients with pleural infection to undergo either medical pleuroscopy or standard chest drain insertion is feasible and acceptable.

Ethics approval

Yorkshire & The Humber - Sheffield Research Ethics Committee, 12/04/2017, ref: 17/YH/0074

Study design

Randomised; Interventional; Design type: Treatment, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other acute lower respiratory infections

Intervention

Those who agree to enrolled are first asked to answer questions about their background and previous health. Eligible participants are randomised in a 1:1 ratio using an online (computer-based) system. Patients are randomised to receive one of two standard procedures. The intervention arm (medical pleuroscopy) entails a procedure lasting approximately 45 minutes. The control arm (chest drain insertion) consists of a procedure lasting approximately 15 minutes.

Intervention arm: Patients will undergo medical pleuroscopy on either the same or next day as they are diagnosed as needing a pleural intervention. They will have the procedure under light conscious sedation and local anaesthetic.

Control arm: Patients will undergo routine chest drain insertion on either the same or the next day as they are diagnosed as needing a pleural intervention. The procedure will be performed under local anaesthetic.

Patients with pleural infection can usually be discharged home after a few days in hospital. During their stay, participants receive standard care and treatment, but are also asked to perform simple breathing tests and answer some questions about their symptoms and quality of life. Participants are followed up at their local hospital by the trial team after one month and three months, when further information about their recovery and symptoms is gathered. About half of the patients enrolled will also be invited to take part in a more in-depth interview about their experiences in the trial.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The feasibility of screening and enrolling patients into the study, and delivering the trial protocol is measured using the proportion of pre-screen failures, screen failures, and allocation failures compared to the total numbers of patients pre-screened, screened, and randomised (respectively).

Secondary outcome measures

1. Duration of stay due to pleural infection is measured by the number of nights in hospital between enrolment and being recorded as medically fit for discharge
2. Total inpatient time is measured by the number of nights in hospital between enrolment and the end of the 90-day post-procedure follow-up period
3. Need for step-up therapy is measured by the difference in proportion of patients requiring intrapleural fibrinolytic therapy or referral for surgical debridement
4. Lung function is measured by the change in spirometry values (FEV1,FVC and FEV1:FVC ratio) at baseline and days 30 and 90
5. All-cause mortality is measured by the number of patients remaining alive at days 30 and 90 post procedure
6. Degree of pleural fluid septation is measured by the change in bedside thoracic ultrasound septation score at baseline and days one, three, seven, 30 and 90 post procedure
7. Pleural effusion size, is measured by the change in radiographic hemithorax opacification from enrolment to discharge, and days one, 30 and 90 post procedure
8. Microbiological yield is measured by the difference in proportion with positive culture or stain between the control and intervention arms at 90 days
9. Total costs of interventions is measured by the difference in total cost of treatment for pleural infection (from enrolment to being medically fit for discharge) between two arms at 90 days post procedure
10. Quality of life is measured by the change in EQ-5D subjective health score at baseline to days 30 and 90 post procedure
11. Patient experiences are assessed by exploring patients’ perceptions and experiences of interventions before and after their procedure through semi-structured interviews at baseline and study end

Overall trial start date

20/07/2016

Overall trial end date

31/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pleural effusion due primarily to suspected pleural infection requiring chest tube drainage, defined as an effusion, in the appropriate clinical context, with one or more of the following characteristics:
1.1. Fluid pH ≤7.20 or visually contains pus
1.2. Pleural fluid glucose ≤3.4 mmol/L
1.3. Positive bacterial or mycobacterial culture
1.4. Positive gram stain or stain for acid-fast bacilli
2. Clinical team are able to perform a medical thoracoscopy, if allocated, on either the same or the next day as the effusion is diagnosed as requiring drainage
3. Clinical team are able to deliver the post-procedure trial schedule as detailed in the protocol
4. Patient is willing to consider trial entry and receive information sheet

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Any contraindication, in the opinion of the trial team or lead clinician, to
1.1. Medical thoracoscopy performed under conscious sedation
1.2. Chest drain insertion
1.3. Trial involvement
2. Patient is unable to provide informed consent
3. Thoracic imaging demonstrating septation or loculation to a degree whereby medical management alone would be inappropriate
4. Maximum pleural fluid depth of ≤2cm on thoracic ultrasound
5. Ongoing sepsis requiring haemodynamic support beyond basic fluid resuscitation
6. Previous thoracic surgery on the side of the effusion
7. Age <18
8. Pregnancy or lactation
9. Expected survival ≤3 months

Recruitment start date

01/08/2017

Recruitment end date

30/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
North Bristol NHS Trust Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Gloucester Royal Hospital
Gloucestershire Hospitals NHS Foundation Trust Great Western Road
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford University Hospitals NHS Foundation Trust Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Wythenshawe Hospital
University Hospital of South Manchester NHS Foundation Trust Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

St Thomas' Hospital
Guy's and St Thomas' NHS Foundation Trust Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Queen Elizabeth University Hospital Glasgow
NHS Greater Glasgow and Clyde 1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Royal Preston Hospital
Lancashire Teaching Hospitals NHS Foundation Trust Sharoe Green Lane North Fulwood
Preston
PR2 9HT
United Kingdom

Sponsor information

Organisation

Southmead Hospital

Sponsor details

North Bristol NHS Foundation Trust
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Academy of Medical Sciences

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at North Bristol NHS Trust.

Intention to publish date

31/08/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes