Randomised ambulatory management of primary pneumothorax (RAMPP)

ISRCTN	ISRCTN79151659
DOI	https://doi.org/10.1186/ISRCTN79151659
Protocol serial number	19214
Sponsor	CTRG (University of Oxford)
Funders	Medical Research Council, National Institute for Health Research

Submission date: 05/08/2015
Registration date: 06/08/2015
Last edited: 12/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Miss Magda Laskawiec-Szkonter
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Ambulatory management of primary pneumothorax: a randomised controlled trial
Study acronym	RAMPP
Study objectives	This study compares ambulatory to standard (in-patient treatment with aspiration/chest drain) management of primary pneumothorax.
Ethics approval(s)	NRES Committee South Central - Oxford A, 19/05/2015, ref: 15/SC/0240
Health condition(s) or problem(s) studied	Pneumothorax
Intervention	1. Ambulatory Device, Rocket Pleural vent insertion 2. Standard Treatment, Aspiration +/- chest drain
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Not provided at time of registration
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/03/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	286
Total final enrolment	236
Key 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
Key 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
Date of first enrolment	27/08/2015
Date of final enrolment	31/03/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Oxford

Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/07/2020	06/07/2020	Yes	No
Protocol article		11/04/2019	12/09/2023	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Cost-effectiveness	17/08/2022	12/09/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/09/2023: Publication references added.
06/07/2020: Publication reference and total final enrolment number added.
07/04/2020: The intention to publish date was changed from 01/04/2020 to 30/06/2020.
27/02/2020: The recruitment start date was changed from 17/06/2015 to 27/08/2015.
03/04/2019: The condition has been changed from "Topic: Injuries and Emergencies, Respiratory; Subtopic: Injuries and Emergencies (All Subtopics), Respiratory (All Subtopics); Disease: Injuries and Emergencies, Respiratory" to "Pneumothorax" following a request from the NIHR.
08/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 31/03/2019.
2. The overall trial end date has been updated from 31/12/2019 to 31/03/2020.
08/03/2018: The intention to publish date has been updated.
22/01/2018: The overall trial end date has been updated from 31/12/2018 to 31/12/2019. The recruitment end date has been updated from 31/12/2017 to 31/12/2018. The intention to publish date has been updated.
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".