Pleural Disease: Phenotypes, Diagnostic Yield and Outcomes

NCT03922841 | Completed DMC

• 1 other identifier: 2018/2125
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural disease i.e. with effusions or pneumothorax have a high disease burden to patients. This is because most patients require diagnostic and therapeutic interventions in the form of drainage and biopsies. With increasing age, the incidence of pleural disease is likely to rise with concomitant rise in pulmonary malignancy and infection. The impact of pleural disease, especially ambulatory drainage depends not only on patient factors such as effusion size, cardiopulmonary co-morbidities and underlying aetiology. It also depends on socioeconomic factors such as ability to afford ambulatory equipment (which is not covered by Medisave), availability of care-givers and coping mechanisms. To phenotype patients presenting to Singapore General Hospital with pleural disease and evaluate impact on outcomes of pleural interventions This study will collect existing or prospective data that is part of standard clinical care

• Source of the data: electronic medical record of patients (ambulatory and inpatient)
• Data will be collected prospectively.

Conditions

Pleural Diseases

Outcome Measures

Primary Outcomes (1)

• Resolution of pleural disease

  As above

  30 days

Study Arms (1)

Subjects with pleural disease

The subject must meet all of the following inclusion criteria to participate in this study. 1. Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed Tomography regardless of underlying aetiology 2. No age or gender restrictions 3. Ability to provide informed consent

Other: Pleural disease management

Interventions

Pleural disease management OTHER

History, physical examination, pleural drainage, lab/radiographic investigations

Subjects with pleural disease

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited if they already have radiographic evidence of pleural disease.

You may qualify if:

• Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed Tomography regardless of underlying aetiology
• No age or gender restrictions
• Ability to provide informed consent

You may not qualify if:

• Subjects who no radiographic evidence of pleural disease or who are unwilling/unable to provide informed consent

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Devanand Anantham, MRCP

  Singhealth Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: March 9, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)