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Enrolling by Invitation

NCT Number: NCT07625176

Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care

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.

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Key information

Conditions

Pleural Diseases Pleural Effusion Pleural Infection Pneumothorax Pneumothorax Spontaneous Primary Pneumothorax Spontaneous Secondary Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • DJ939

Pleural effusion:

  • DJ90
  • DJ909
  • DJ919
  • DJ91
  • DJ940
  • DJ948
  • DJ948A
  • DJ949
  • DC782

Pleural infection:

  • DJ86
  • DJ860
  • DJ860

Exclusion criteria

  • Traumatic pneumothorax (including iatrogenic pneumothorax)
  • Hemothorax

Treatment and study plan

Clinical decision-making support tool

Behavioral

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 Care

Other

Care supported by a clinical decision-support tool delivered via a smartphone app.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correct pneumothorax subtype classification

    Time frame: During index hospital admission (up to 90 days after admission)

    Whether the pneumothorax subtype was correctly classified during the index hospital admission according to predefined diagnostic criteria (yes/no).

  2. Number of participants receiving each initial pneumothorax management strategy

    Time frame: Within 24 hours from hospital admission

    Number of participants managed with either conservative care, needle aspiration, chest tube insertion, or ambulatory device insertion

  3. Chest tube size

    Time frame: Periprocedural.

    Diameter of chest tube used for treatment of spontaneous pneumothorax, reported in French units (Fr).

  4. 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 with ongoing air leak through the chest drainage system for more than 7 days after chest tube insertion (yes/no)

  5. Number of participants undergoing high-resolution computed tomography (HRCT)

    Time frame: During index hospital admission

    Number of participants who underwent high-resolution computed tomography (HRCT) during hospital admission or within 90 days after discharge, recorded as yes/no

  6. 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).

    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.

  7. Chest tube size

    Time frame: Periprocedural

    Chest tube size (French gauge, Fr) used for pleural effusion drainage

  8. Definitive cause for pleural effusion

    Time frame: During hospital admission or within 90 days after discharge.

    Was a definitive cause for the cause of pleural effusion established.

  9. Definitive pleural procedure

    Time frame: During hospital admission or within 90 days after discharge.

    Definitive pleural procedure within 90 days of admission due to pleural effusion.

  10. Number of participants receiving complete recommended diagnostic work-up for suspected pleural infection

    Time frame: Up to 90 days

    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.

  11. Chest tube diameter of chest tubes used for pleural infection.

    Time frame: Periprocedural.

    Diameter of chest tube used for drainage of pleural infection, reported in French units (Fr).

  12. Number of participants receiving intrapleural enzyme therapy (IET) for pleural infection.

    Time frame: Up to 90 days.

    Assessment of whether intrapleural enzyme therapy (IET) was administered in participants with pleural infection despite chest tube drainage.

  13. Length of antibiotic treatment

    Time frame: During hospital admission or within 90 days after discharge.

    Total length of antibiotic treatment (both intravenously and orally) for pleural infection.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study 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.

Acronym: APPLAUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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