An interventional study of Clinical decision-making support tool and Usual care in Pleural Diseases, Pneumothorax Spontaneous Primary and Pneumothorax Spontaneous Secondary, sponsored by Zealand University Hospital. Enrolling by invitation at 10 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment
Pleural disease is a group of conditions that affect the membrane around the lungs. These conditions-fluid around the lungs, infections, cancer, and collapsed lung-are common and can cause serious illness. They often lead to long hospital stays, emergency admissions, and reduced quality of life. In Denmark and worldwide, the number of patients with pleural disease is rising, and the treatment is costly for the healthcare system.
How long patients stay in the hospital depends on the type of pleural disease. Some stay less than a week, while others remain for several weeks, especially if complications occur. Research shows that early diagnosis and treatment based on clinical guidelines can shorten hospital stays and improve outcomes.
In the UK, many hospitals have created dedicated pleural clinics run by specialists. These clinics help ensure that patients receive fast, consistent, and evidence based care, and they have reduced the number of days patients spend in hospital. In Denmark, however, such clinics are rare. A recent national survey showed that many Danish hospitals do not follow current pleural disease guidelines, and many lack clear pathways for diagnosing and treating these patients. As a result, patients may receive suboptimal care.
This project aims to close that gap. The goal is to develop an easy to use, guideline based decision tool that supports doctors in emergency, medical, and surgical departments. The tool will guide clinicians from the moment a patient arrives until discharge, helping them choose the right tests and treatments at the right time. By making expert knowledge accessible to non specialists, the project hopes to improve patient care, reduce complications, and shorten hospital stays.
Ultimately, the project seeks to ensure that all patients with pleural disease in Denmark receive fast, safe, and evidence based treatment-no matter where they are admitted.
51 studies on the registry are indexed under Pleural Diseases; 12 are open to participants now.
This study's planned enrollment of 828 is above the median of 77 across 32 interventional studies indexed under Pleural Diseases.
Browse Pleural Diseases studies →Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One or more of the following, relevante ICD-10 codes for either spontaneous pneumothorax, pleural effusion or pleural infection.
Spontaneous pneumothorax:
Pleural effusion:
Pleural infection:
Exclusion Criteria:
Usual provided care for patients with spontaneous pneumothorax, pleural effusion or pleural infection. All clusters begin in this condition before transitioning to the intervention as part of the stepped-wedge schedule.
Other: Usual care
Care supported by the clinical decision-making app. Clusters transition to this condition at predefined time points according to the stepped-wedge design.
Behavioral: Clinical decision-making support tool
Care for patients with spontaneous pneumothorax, pleural effusion or pleural infection when supported by a clinical decision-support tool, in the form of a smartphone app.
Care supported by a clinical decision-support tool delivered via a smartphone app.
Length of hospital stay (days)
Number of days from hospital admission to hospital discharge.
Time frame: From hospital admission through hospital discharge (up to 90 days)
Correct pneumothorax subtype classification
Whether the pneumothorax subtype was correctly classified during the index hospital admission according to predefined diagnostic criteria (yes/no).
Time frame: During index hospital admission (up to 90 days after admission)
Number of participants receiving each initial pneumothorax management strategy
Number of participants managed with either conservative care, needle aspiration, chest tube insertion, or ambulatory device insertion
Time frame: Within 24 hours from hospital admission
Chest tube size
Diameter of chest tube used for treatment of spontaneous pneumothorax, reported in French units (Fr).
Time frame: Periprocedural.
Number of participants with persistent air leak (>7 days)
Number of participants with ongoing air leak through the chest drainage system for more than 7 days after chest tube insertion (yes/no)
Time frame: From chest tube insertion until resolution of air leak or up to 90 days
Number of participants undergoing high-resolution computed tomography (HRCT)
Number of participants who underwent high-resolution computed tomography (HRCT) during hospital admission or within 90 days after discharge, recorded as yes/no
Time frame: During index hospital admission
Number of participants receiving complete recommended diagnostic work-up for unilateral pleural effusion
Assessment of whether recommended blood tests (full blood count, C-reactive protein, renal function tests, liver function tests, and albumin) and pleural fluid analyses (pH or glucose, LDH, leukocyte differential count, microbiology culture and sensitivity analysis, and cytology) were performed in participants with unilateral pleural effusion.
Time frame: At end of index hospital admission (up to 90 days).
Chest tube size
Chest tube size (French gauge, Fr) used for pleural effusion drainage
Time frame: Periprocedural
Definitive cause for pleural effusion
Was a definitive cause for the cause of pleural effusion established.
Time frame: During hospital admission or within 90 days after discharge.
Definitive pleural procedure
Definitive pleural procedure within 90 days of admission due to pleural effusion.
Time frame: During hospital admission or within 90 days after discharge.
Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection
Assessment of whether recommended blood tests (full blood count, C-reactive protein, renal function tests, liver function tests, and albumin) and pleural fluid analyses (pH or glucose, LDH, leukocyte differential count, microbiology culture and sensitivity analysis, and cytology) were performed in participants with suspected pleural infection.
Time frame: Up to 90 days
Chest tube diameter of chest tubes used for pleural infection.
Diameter of chest tube used for drainage of pleural infection, reported in French units (Fr).
Time frame: Periprocedural.
Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection.
Assessment of whether intrapleural enzyme therapy (IET) was administered in participants with pleural infection despite chest tube drainage.
Time frame: Up to 90 days.
Length of antibiotic treatment
Total length of antibiotic treatment (both intravenously and orally) for pleural infection.
Time frame: During hospital admission or within 90 days after discharge.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Oct 2026, 6 months after the start.
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