Pleural DiseasesAPPLAUSNCT07625176
Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care
A study testing Clinical decision-making support tool in people with Pleural Diseases and Pneumothorax Spontaneous Primary, run by Zealand University Hospital at 10 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases, Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary
- What is being tested?
- Clinical decision-making support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 828 participants
- Where
- 10 sitesDenmark
- Study dates
- 1 Apr 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One or more of the following, relevante ICD-10 codes for either spontaneous pneumothorax, pleural effusion or pleural infection.
- Spontaneous pneumothorax:
- DJ93
- DJ930
- DJ931
- DJ938
Show all 21Show fewer
- DJ939
- Pleural effusion:
- DJ90
- DJ909
- DJ919
- DJ91
- DJ940
- DJ948
- DJ948A
- DJ949
- DC782
- Pleural infection:
- DJ86
- DJ860
- DJ860
Who cannot join
- Traumatic pneumothorax (including iatrogenic pneumothorax)
- Hemothorax
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Denmark10 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8200
Amager Hospital
Amager, 2300
Esbjerg Hospital
Esbjerg, 6700
North Zealand Hospital, Hillerød
Hillerød, 3400
Hvidovre Hospital
Hvidovre, 2650
Zealand University Hospital, Køge
Køge, 4600
Kolding Hospital
Kolding, 6000
Odense University Hospital
Odense, 5000
Slagelse Hospital
Slagelse, 4200
About this study
Official title: Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care: a Multicentre, Stepped-wedge Cluster-randomised Controlled Trial to Reduce Number of Days in Hospital.
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.
Read more
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.
- Conditions
- Pleural Diseases, Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion, Pleural Infection
- Being tested
- Clinical decision-making support tool, Usual care
- Medical subject headings
- Pleural Diseases, Pneumothorax, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision-making support toolBehavioural
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.
Usual careOther
Care supported by a clinical decision-support tool delivered via a smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | 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. Receives: Other: Usual care |
| Clinical decision-making support tool | Experimental | Care supported by the clinical decision-making app. Clusters transition to this condition at predefined time points according to the stepped-wedge design. Receives: Behavioral: Clinical decision-making support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (days)
Number of days from hospital admission to hospital discharge.
Measured: From hospital admission through hospital discharge (up to 90 days)
Secondary outcomes (13)
Correct pneumothorax subtype classification
Whether the pneumothorax subtype was correctly classified during the index hospital admission according to predefined diagnostic criteria (yes/no).
Measured: 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
Measured: Within 24 hours from hospital admission
Chest tube size
Diameter of chest tube used for treatment of spontaneous pneumothorax, reported in French units (Fr).
Measured: 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)
Measured: 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
Measured: 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.
Measured: At end of index hospital admission (up to 90 days).
Chest tube size
Chest tube size (French gauge, Fr) used for pleural effusion drainage
Measured: Periprocedural
Definitive cause for pleural effusion
Was a definitive cause for the cause of pleural effusion established.
Measured: During hospital admission or within 90 days after discharge.
Definitive pleural procedure
Definitive pleural procedure within 90 days of admission due to pleural effusion.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 90 days.
Length of antibiotic treatment
Total length of antibiotic treatment (both intravenously and orally) for pleural infection.
Measured: During hospital admission or within 90 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Apr 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster-randomized controlled trial. All clusters begin in the control condition and cross over to the intervention at randomized time points.
- Masking
- None (open label)
- Enrolment
- 828 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uffe Bodtger, Zealand University Hospital
- Investigators
- Casper Jensen, MD, Principal investigator, Lungemedicinsk Forskningsenhed (PLUZ), Institut for Regional Sundhedsforskning, Syddansk Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625176
- Sponsor's protocol ID
- p-2024-17577
- Acronym
- APPLAUS
- Status last verified
- May 2026
- First submitted
- 20 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care: a Multicentre, Stepped-wedge Cluster-randomised Controlled Trial to Reduce Number of Days in Hospital.
- ClinicalTrials.gov ID
- NCT07625176
- Acronym / sponsor ID
- APPLAUS / p-2024-17577
- Conditions
- Pleural Diseases, Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion, Pleural Infection
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 828 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster-randomized controlled trial. All clusters begin in the control condition and cross over to the intervention at randomized time points.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careUsual 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. |
| Clinical decision-making support tool | Experimental | Behavioral: Clinical decision-making support toolCare supported by the clinical decision-making app. Clusters transition to this condition at predefined time points according to the stepped-wedge design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- One or more of the following, relevante ICD-10 codes for either spontaneous pneumothorax, pleural effusion or pleural infection.
- DJ93
- DJ930
- DJ931
- DJ938
Key exclusion criteria (2 listed)
- Traumatic pneumothorax (including iatrogenic pneumothorax)
- Hemothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision-making support toolCare 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. | Behavioural | Clinical decision-making support tool |
| Usual careCare supported by a clinical decision-support tool delivered via a smartphone app. | Other | Usual care |
Primary outcome
Length of hospital stay (days)
Time frame: From hospital admission through hospital discharge (up to 90 days)
Number of days from hospital admission to hospital discharge.
13 secondary outcomes
Correct pneumothorax subtype classification
Time frame: During index hospital admission (up to 90 days after admission)
Number of participants receiving each initial pneumothorax management strategy
Time frame: Within 24 hours from hospital admission
Chest tube size
Time frame: Periprocedural.
Number of participants with persistent air leak (>7 days)
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)
Time frame: During index hospital admission
Number of participants receiving complete recommended diagnostic work-up for unilateral pleural effusion
Time frame: At end of index hospital admission (up to 90 days).
Chest tube size
Time frame: Periprocedural
Definitive cause for pleural effusion
Time frame: During hospital admission or within 90 days after discharge.
Definitive pleural procedure
Time frame: During hospital admission or within 90 days after discharge.
Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection
Time frame: Up to 90 days
Chest tube diameter of chest tubes used for pleural infection.
Time frame: Periprocedural.
Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection.
Time frame: Up to 90 days.
Length of antibiotic treatment
Time frame: During hospital admission or within 90 days after discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Casper Jensen, MD principal investigator
Lungemedicinsk Forskningsenhed (PLUZ), Institut for Regional Sundhedsforskning, Syddansk Universitet
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision-making support tool in people with Pleural Diseases and Pneumothorax Spontaneous Primary, run by Zealand University Hospital at 10 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (days) (time frame: From hospital admission through hospital discharge (up to 90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.