Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
PROSPECT
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 8, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJune 18, 2023
June 1, 2023
3.9 years
June 8, 2023
June 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Complications
Specifically: bleeding, infection, pneumothorax, organ injury, pain, re-expansion pulmonary oedema
within 30 days
Secondary Outcomes (1)
Patient reported outcome measures of dyspnoea and chest pain
within 4 weeks
Study Arms (1)
Undergoing pleural intervention
Any patient undergoing a pleural procedure (eg thoracocentesis, chest drain, indwelling pleural catheter, pleural biopsies, medical thoracoscopy)
Interventions
eg thoracocentesis, chest drain, indwelling pleural catheters, thoracoscopy
Eligibility Criteria
\- Patients undergoing invasive pleural intervention in a variety of settings: day case procedure lists, pleural clinic, bedside
You may qualify if:
- Aged \>18
- Undergoing pleural intervention
- Able to provide written informed consent
You may not qualify if:
- Aged \<18
- Unable to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Beckton Dickinsoncollaborator
Study Sites (1)
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Najib Rahman, DPhil
University of Oxford
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2023
First Posted
June 18, 2023
Study Start
September 1, 2020
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
June 18, 2023
Record last verified: 2023-06