Condition category
Respiratory
Date applied
05/08/2015
Date assigned
06/08/2015
Last edited
15/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pneumothorax - air in the pleural space, or more widely known as a collapsed lung - is common (~3,000 patients per year in the UK). The term primary spontaneous pneumothorax (PSP) is used to describe those cases that occur in the absence of trauma, in patients with no underlying established lung disease. Not all patients need to have treatment; such patients are just closely observed until the condition improves on its own. However, many patients will need treatment to re-inflate the lung. In some cases aspiration (removal) of air from the pleural space using cannula and syringe will be enough, but many will need to have a chest drain inserted with standard underwater seal. The average hospital in-patient stay for people having this treatment is 6-8 days. Portable ‘ambulatory’ devices (such as the Rocket Pleural Vent) provide the option to treat these patients as an outpatient while their lung reinflates. This study compares ambulatory to standard (in-patient treatment with aspiration/chest drain) management of primary pneumothorax.

Who can participate?
Participants aged between 16 and 55 with a PSP.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 undergo ambulatory management of their PSP. Those in group 2 undergo standard (in-patient treatment with aspiration/chest drain) management of their PSP. Primary outcome is total hospital stay up for up to 30 days. The study also investigates whether digitally measured air leak can predict short term outcome (prolonged air leak and requirement for surgery) and whether radiological evidence (on CT scanning) of emphysema-like change and inflammation (swelling of the lung) can predict long term outcome (recurrence rates at 12 months). Patients are assessed at the start of the study with blood tests taken and are reviewed daily either on the ward (standard management group) or as an outpatient (ambulatory group) with chest x-ray, air leak measurement and assessment of breathlessness and chest discomfort. Patients who do not require treatment, will be invited to participate in the observational part of the study and after their initial assessment will be discharged but return for follow up. All patients are followed-up at 1 week post treatment completion (including a CT scan at 2 weeks post completion of treatment), and then at 1, 6 & 12 months after the start of the study.

What are the possible benefits and risks of participating?
One potential benefit of taking part in the study is that those randomly assigned to portable device have the opportunity to be discharged with the device in place. Any procedure on the chest carries some risk. Most patients having a chest drain do not have any problems. However, occasionally patients may experience pain, bleeding or infection at the site of the drain. This risk is the same whether they are in the trial of not. If a patient is enrolled after already having had a chest drain, they may require an extra procedure if they are randomised to the ambulatory device. Patients have at least 6 chest x-rays during their participation in this study, although 4 of these would need to be done whether they were in the study or not. They will also have a CT scan (for research). There are theoretical health risks from excessive radiation exposure, but chest x-rays are the safest tests (the radiation dose is only equivalent to around four days’ worth of normal background radiation) and the CT scan will be the lowest possible dose (equivalent of one year’s worth of normal background radiation).

Where is the study run from?
University of Oxford, Churchill Hospital (UK)

When is the study starting and how long is it expected to run for?
July 2015 to December 2018

Who is funding the study?
Medical Research Council and the National Institute for Health Research (UK)

Who is the main contact?
Miss Magda Laskawiec-Szkonter

Trial website

Contact information

Type

Scientific

Primary contact

Miss Magda Laskawiec-Szkonter

ORCID ID

Contact details

University of Oxford
Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19214

Study information

Scientific title

Ambulatory management of primary pneumothorax: a randomised controlled trial

Acronym

RAMPP

Study hypothesis

This study compares ambulatory to standard (in-patient treatment with aspiration/chest drain) management of primary pneumothorax.

Ethics approval

NRES Committee South Central - Oxford A, 19/05/2015, ref: 15/SC/0240

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Injuries and Emergencies, Respiratory; Subtopic: Injuries and Emergencies (All Subtopics), Respiratory (All Subtopics); Disease: Injuries and Emergencies, Respiratory

Intervention

1. Ambulatory Device, Rocket Pleural vent insertion
2. Standard Treatment, Aspiration +/- chest drain

Intervention type

Device

Phase

Drug names

Primary outcome measures

To assess whether use of an ambulatory device (Rocket Pleural Vent) and treatment strategy reduces hospital stay. Total length of stay in hospital up to 30 days post randomisation. Up to 30 days post randomisation.

Secondary outcome measures

1. Determine whether digitally measured air leak and its evolution over treatment, can predict short term clinical trajectory in patients with pneumothorax, including requirement for prolonged drainage and need for thoracic surgical intervention
1.1. Digitally measured air leak (using Thopaz device), from day 0 (immediately post intervention) to day 4 (or until the chest drain/device removal)
1.2. Rate of surgical referral/failure of medical therapy, on day 4
1.3. Number of pleural procedures required during primary admission, from primary admission until completion of treatment
1.4. Rate of lung re-expansion by comparing the percentage of the hemithorax occupied by the pneumothorax using a CXR scoring system, daily until completion of treatment
2. Establish whether radiological evidence (on CT scanning) of emphysema-like changes (ELC) and inflammation, and serum markers of inflammation can predict long term outcome. Measured at 1 week post completion of treatment and 1, 6 and 12 months post enrolment assessed at follow-up clinic.
2.1.CT evidence of ELC and inflammation: number and size of bullae at apices, and bronchial wall thickness in lung apices (surrogate for inflammation), measured at 1 week post completion of treatment and 1, 6 and 12 months post enrolment assessed at follow-up clinic.
2.2. Correlation with recurrence rate (and time to recurrence) assessed at follow-up clinic
2.3. Serum highly sensitive C-reactive protein (CRP) level on blood test. Measured at baseline.
3. Assess whether ambulatory care and early discharge is safe and cost-effective in the treatment of PSP.
3.1. Rate of complications: intervention site bleeding or infection, blockage of device and need for additional procedure. Measured from initial admission until 1 week post completion of treatment.
3.2. NHS-related healthcare costs by including use of equipment and devices, consumables, medications, and staff and theatre, initial and subsequent hospitalisations over the 12 month follow-up, and outpatient contacts.
3.3. Incremental cost per QALY gained when ambulatory care is compared to standard care, measured from initial admission throughout follow-up.
4. Determine whether patient experience is improved with an ambulatory device (Rocket Pleural Vent): pain of procedure, breathlessness, quality of life assessments (EQ-5D-5L), and time to return to working status.
4.1. Patient related factors: procedural pain/discomfort and breathlessness on VAS scoring system, analgesia usage, and generic health-related and disease-specific quality of life as measured using the Euroqol 5 dimensions 5 levels (EQ-5D-5L). Measured from initial admission throughout follow-up.
4.2. Time to return to work and total days off work, measured from initial admission throughout follow-up.
5. Assess recurrence rate of pneumothorax. Radiological evidence (CXR and or CT) of recurrence. Measured at 1 week post completion of treatment and at 1, 6 and 12 months post enrolment assessed at follow-up clinic.

Overall trial start date

28/09/2014

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Presenting with primary spontaneous pneumothorax as confirmed by a chest radiograph or a CT scan
2. Age >= 16 years old and <= 55 years old
3. Ability to consent to participation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

286

Participant exclusion criteria

1. Known or suspected underlying lung disease (including >20 pack year smoking history)
2. Evidence of tension pneumothorax (these patients should be treated immediately as medical emergencies).
3. Females who are pregnant or lactating
4. Inability to consent or comply with the trial requirements
5. Contraindication to thoracic procedure. (Only applies to patients being enrolled into Intervention or Control arms – i.e. not observational cohort)
6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial

Recruitment start date

17/06/2015

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Churchill Hospital Old Road
Oxford
OX3 7LE
United Kingdom

Sponsor information

Organisation

CTRG (University of Oxford)

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of this research will be submitted to the international meetings of respiratory medicine (American Thoracic Society, European Respiratory Society and British Thoracic Society meetings) in abstract form on completion of initial results, with final submission for publication in a high impact respiratory or general medical journal. The findings of this study would be expected to be included in the national treatment guidelines for management of primary pneumothorax on their next iterations. Dissemination of results would in parallel occur through websites and national bodies such as the British Thoracic Society and British Lung Foundation, once the results of the study had been peer reviewed and accepted for publication. We are planning to submit about 6 months after the completion of the study.

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/08/2016: Changed overall study end date from 30/09/2017 to 31/12/2018. Changed recruitment end date from 30/09/2017 to 31/12/2017. Changed age range of participants from "18 to 55" to "16 to 55" .