Pleural DiseasesPROSPECTNCT05910112
Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
An observational study of Pleural Diseases and Pleural Mesothelioma, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The PROSPECT study aims to look at the number of problems or side effects which occur after patients have had a procedure completed to remove fluid or air from the space between the lung and the chest wall. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pleural Diseases, Pleural Mesothelioma, Pneumothorax
- What is being tested?
- Pleural interventions
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Patients undergoing invasive pleural intervention in a variety of settings: day case procedure lists, pleural clinic, bedside
Who may be able to join
- Aged >18
- Undergoing pleural intervention
- Able to provide written informed consent
Who cannot join
- Aged <18
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
Emma P Hedley, +441865225205, Emma.Hedley@ouh.nhs.uk
Najib Rahman
About this study
The PROSPECT study aims to look at the number of problems or side effects which occur after patients have had a procedure completed to remove fluid or air from the space between the lung and the chest wall. Other information will also be collected to see whether anything else affects which patients have problems after the procedure such as bleeding or infection. This study will also investigate whether it is possible to find out which patients are likely to feel a lot better after the procedure. Not all patients feel significantly better but it is not clear why this is. There are a number of different reasons patients may not feel better, for example if the lung is not able to fully re-expand. The study aims to look at whether it is possible to predict these problems before the procedure using ultrasound. If it is possible to find the answers to some of these questions it might be possible to prevent patients undergoing treatments which are not likely to benefit them. The study will use information already collected as part of clinical care, as well as questionnaires from patients receiving care at a variety of centres. The different features of these centres will also be considered in analysis.
Read the detailed description
PROSPECT is a prospective, observational study in which complications and key other data will be collected from patients undergoing pleural procedures. Data will include demographics, smoking history, pre-procedure observations, radiological findings and medical history along with information about the size of the service and range of procedures performed. Complications will be objectively defined, with baseline procedure information recorded, and at 1 month, all complications recorded according to specified criteria.
At least 20 centres will be approached to collect prospective data on pleural interventions and outcomes for patients who have undergone procedures in their service. All patients who have a pleural procedure for fluid will have an ultrasound as part of the procedure but due to a difference in expertise around the country, centres (and clinicians within each centre) will record ultrasound findings in varying degrees of detail. Centres will specify what level of detail they can provide and can opt to perform a more detailed assessment if skills permit and the patient agrees. Any patient can be included in the sub-study if there is sufficient time and sufficient expertise of the clinicians to perform and interpret the more detail scanning procedures.
Patients, who are willing, will also be asked to complete a visual analogue scale score for chest pain and breathlessness before and after their procedure and at a further time interval within 4 weeks. Any patients who are having an indwelling catheter inserted, or chest drain inserted for pleurodesis will be asked to complete an additional questionnaire.
The majority of centres will be those with an active pleural service and will include a combination of district general and tertiary referral centres. The data is likely to represent best practice but should also include the complex cases and interventions. In the future, the study is extendable to non-specialist centres to achieve similar reporting standards, mirroring current standards in other areas such as surgery. The data collected will provide a "best practice standard" against which new and smaller volume centres can benchmark practice, to ensure patient safety.
- Conditions
- Pleural Diseases, Pleural Mesothelioma, Pneumothorax, Pleural Effusion, Pleural Infection, Pleural Neoplasms
- Being tested
- Pleural interventions
- Medical subject headings
- Pleural Diseases, Mesothelioma, Malignant, Pneumothorax, Pleural Effusion, Pleural Neoplasms, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural interventionsProcedure or surgery
eg thoracocentesis, chest drain, indwelling pleural catheters, thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| Undergoing pleural intervention | Any patient undergoing a pleural procedure (eg thoracocentesis, chest drain, indwelling pleural catheter, pleural biopsies, medical thoracoscopy) Receives: Procedure: Pleural interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Specifically: bleeding, infection, pneumothorax, organ injury, pain, re-expansion pulmonary oedema
Measured: within 30 days
Secondary outcomes (1)
Patient reported outcome measures of dyspnoea and chest pain
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Sep 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Beckton Dickinson
- Responsible party
- Sponsor
- Investigators
- Najib Rahman, DPhil, Study chair, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910112
- Sponsor's protocol ID
- 260269
- Acronym
- PROSPECT
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
- ClinicalTrials.gov ID
- NCT05910112
- Acronym / sponsor ID
- PROSPECT / 260269
- Conditions
- Pleural Diseases, Pleural Mesothelioma, Pneumothorax, Pleural Effusion, Pleural Infection, Pleural Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Beckton Dickinson
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PROSPECT study aims to look at the number of problems or side effects which occur after patients have had a procedure completed to remove fluid or air from the space between the lung and the chest wall. Other information will also be collected to see whether anything else affects which patients have problems after the procedure such as bleeding or infection. This study will also investigate whether it is possible to find out which patients are likely to feel a lot better after the procedure. Not all patients feel significantly better but it is not clear why this is. There are a number of different reasons patients may not feel better, for example if the lung is not able to fully re-expand. The study aims to look at whether it is possible to predict these problems before the procedure using ultrasound. If it is possible to find the answers to some of these questions it might be possible to prevent patients undergoing treatments which are not likely to benefit them. The study will use information already collected as part of clinical care, as well as questionnaires from patients receiving care at a variety of centres. The different features of these centres will also be considered in analysis.
Detailed description
PROSPECT is a prospective, observational study in which complications and key other data will be collected from patients undergoing pleural procedures. Data will include demographics, smoking history, pre-procedure observations, radiological findings and medical history along with information about the size of the service and range of procedures performed. Complications will be objectively defined, with baseline procedure information recorded, and at 1 month, all complications recorded according to specified criteria.
At least 20 centres will be approached to collect prospective data on pleural interventions and outcomes for patients who have undergone procedures in their service. All patients who have a pleural procedure for fluid will have an ultrasound as part of the procedure but due to a difference in expertise around the country, centres (and clinicians within each centre) will record ultrasound findings in varying degrees of detail. Centres will specify what level of detail they can provide and can opt to perform a more detailed assessment if skills permit and the patient agrees. Any patient can be included in the sub-study if there is sufficient time and sufficient expertise of the clinicians to perform and interpret the more detail scanning procedures.
Patients, who are willing, will also be asked to complete a visual analogue scale score for chest pain and breathlessness before and after their procedure and at a further time interval within 4 weeks. Any patients who are having an indwelling catheter inserted, or chest drain inserted for pleurodesis will be asked to complete an additional questionnaire.
The majority of centres will be those with an active pleural service and will include a combination of district general and tertiary referral centres. The data is likely to represent best practice but should also include the complex cases and interventions. In the future, the study is extendable to non-specialist centres to achieve similar reporting standards, mirroring current standards in other areas such as surgery. The data collected will provide a "best practice standard" against which new and smaller volume centres can benchmark practice, to ensure patient safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergoing pleural intervention | – | Procedure: Pleural interventionsAny patient undergoing a pleural procedure (eg thoracocentesis, chest drain, indwelling pleural catheter, pleural biopsies, medical thoracoscopy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients undergoing invasive pleural intervention in a variety of settings: day case procedure lists, pleural clinic, bedside
Key inclusion criteria (3 listed)
- Aged >18
- Undergoing pleural intervention
- Able to provide written informed consent
Key exclusion criteria (2 listed)
- Aged <18
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural interventionseg thoracocentesis, chest drain, indwelling pleural catheters, thoracoscopy | Procedure or surgery | Undergoing pleural intervention |
Primary outcome
Complications
Time frame: within 30 days
Specifically: bleeding, infection, pneumothorax, organ injury, pain, re-expansion pulmonary oedema
1 secondary outcome
Patient reported outcome measures of dyspnoea and chest pain
Time frame: within 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najib Rahman, DPhil study chair
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Diseases and Pleural Mesothelioma, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anand Sundaralingam, MBBS (01865226767 ext. 26767, Anand.Sundaralingam@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.