Clinical trial NCT05910112: Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
Official title: Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleural Diseases
Pleural Mesothelioma
Pneumothorax
Pleural Effusion
Pleural Infection
Pleural Neoplasms
Pleural Metastases
Pleural Effusion, Malignant
Procedural Complication
Complications, Pulmonary
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Beckton Dickinson
First posted: 2023-06-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Patients undergoing invasive pleural intervention in a variety of settings: day case procedure lists, pleural clinic, bedside

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Aged \>18
* Undergoing pleural intervention
* Able to provide written informed consent

Exclusion Criteria:

* Aged \<18
* Unable to provide written informed consent

Primary outcomes:
measure: Complications
timeFrame: within 30 days
Secondary outcomes:
measure: Patient reported outcome measures of dyspnoea and chest pain
timeFrame: within 4 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Najib Rahman, DPhil
role: STUDY_CHAIR
References: