Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05910112 |
| Other study ID # |
260269 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Oxford |
| Contact |
Anand Sundaralingam, MBBS |
| Phone |
01865226767 |
| Email |
Anand.Sundaralingam[@]ndm.ox.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
