Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention (PROSPECT)

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumothorax; Pleural Diseases; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Procedural Complication; Pleural Infection; Pleural Mesothelioma; Complications, Pulmonary; Pleural Metastases
• Intervention / Treatment: Procedure: Pleural interventions

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Anand Sundaralingam, MBBS; Phone Number: 26767 01865226767; Email: Anand.Sundaralingam@ndm.ox.ac.uk
• Study Contact Backup: Name: Emma Hedley; Phone Number: 26767 01865226767; Email: Emma.Hedley@ndm.ox.ac.uk

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Recruiting
      • Oxford University Hospitals NHS Foundation Trust
      • Contact: Emma P Hedley; Phone Number: +441865225205; Email: Emma.Hedley@ouh.nhs.uk
      • Principal Investigator: Najib Rahman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

- Patients undergoing invasive pleural intervention in a variety of settings: day case procedure lists, pleural clinic, bedside

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Aged <18
• Unable to provide written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Undergoing pleural intervention; Any patient undergoing a pleural procedure (eg thoracocentesis, chest drain, indwelling pleural catheter, pleural biopsies, medical thoracoscopy)	Procedure: Pleural interventions; eg thoracocentesis, chest drain, indwelling pleural catheters, thoracoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Specifically: bleeding, infection, pneumothorax, organ injury, pain, re-expansion pulmonary oedema	within 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient reported outcome measures of dyspnoea and chest pain	within 4 weeks

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Beckton Dickinson
• Investigators: Study Chair: Najib Rahman, DPhil, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Adenoma; Neoplasms, Mesothelial; Pneumothorax; Mesothelioma; Pleural Effusion, Malignant; Pleural Effusion; Pleural Diseases; Pleural Neoplasms
• Other Study ID Numbers: 260269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No