Pleural EffusionsNCT06709456
Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
A study testing Ultrasonography-guided pleural drainage in people with Pleural Effusions and Respiratory Failure, run by Olav Schjørring at 6 sites in Denmark.
Trial summary
This trial evaluates the feasibility of ultrasound-guided pleural drainage versus no drainage in adult ICU patients with pleural effusions (fluid buildup around the lungs) and respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusions, Respiratory Failure
- What is being tested?
- Ultrasonography-guided pleural drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 6 sitesDenmark
- Study dates
- 2 Dec 2024to Oct 2025
- Phase
- Interventional
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
- Acute admission to the ICU.
- Age ≥ 18 years.
- Pleural effusion ≥ 2 cm in either pleural cavity assessed by ultrasonography, computed tomography or magnetic resonance imaging (measured between the parietal and visceral pleura perpendicularly to the chest wall at the largest-separation point).
- Respiratory failure defined as one or more of the following: any oxygen supplementation in an open system, invasive or non-invasive mechanical ventilation (including non-intermittent mask CPAP), or most recent arterial blood gas analysis with arterial partial pressure of carbon dioxide (PaCO2) > 6.0 kPa and pH < 7.35.
Who cannot join
- Mediastinal drain or pleural drain in situ on either side.
- Suspected or confirmed haemothorax (e.g., due to recent thoracic trauma or intrathoracic surgery).
- Suspected or confirmed pneumothorax (e.g., by anamnesis, on radiographic or ultrasonographic assessment, or by clinical presentation, e.g., due to presence of subcutaneous emphysema).
- Suspected or confirmed pleural empyema (e.g., by anamnesis or clinical presentation, or on CT, MRI or ultrasonographic assessment).
- Pleural malignancy (suspected or confirmed pleural lymphoma, pleural metastases or direct pleural invasion, or malignant mesothelioma).
- Antithrombotic treatment or coagulation deficiency incompatible with conducting pleural drainage as by local recommendations, and contraindications to reversal of this (clinical assessment).
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- Clinically assessed absolute indication for therapeutic pleural drainage and:
- invasive or non-invasive mechanical ventilation or mask CPAP with PaO2/FiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.
- high-flow humidified oxygen therapy with a flow ≥ 50 L/min and a PaO2/FiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.
- persistent respiratory acidosis with a pH < 7.25 and a PaCO2 > 6.0 kPa in the most recent ABG analysis in spite of non-invasive ventilation for > 1 hour.
- Withdrawal from active therapy or brain death deemed imminent.
- Expected ICU stay < 24 hours from randomisation.
- Pregnancy (in females < 60 years of age, non-pregnancy must be confirmed by a negative urine or plasma human chorionic gonadotropin, or presence a condition incompatible with pregnancy, e.g., previous hysterectomy, or conducted caesarean section during current hospitalisation).
- Under coercive measures (i.e., ongoing involuntary hospital admission or under correctional authorities' jurisdiction).
- Consent not obtainable as per Danish legislation.
- Previously randomised in the DOPE-ICU feasibility trial.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
Aalborg, 9000
Marie S Worm, MD, +45 97 66 19 24, marie.worm@rn.dk
Olav L Schjørring, MD, PhD, +45 97 66 19 21, o.schjoerring@rn.dk
- Recruiting
ICU department 4131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Morten H Møller, MD, PhD, +45 35 45 86 85, morten.hylander.moeller@regionh.dk
- Recruiting
Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
Hillerød, 3400
Morten H Bestle, MD, PhD, +45 48 29 20 17, morten.bestle@regionh.dk
- Not yet recruiting
Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
Køge, 4600
Lars PK Andersen, MD, PhD, +45 56 63 15 00, lapan@regionsjaelland.dk
- Recruiting
Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
Kolding, 6000
Anne C Brøchner, MD, PhD, +45 76 36 31 14, anne.craveiro.broechner@rsyd.dk
- Not yet recruiting
Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
Roskilde, 4000
Henrik P Pedersen, MD, +45 46 32 32 00, hppd@regionsjaelland.dk
About this study
Official title: Drainage of Pleural Effusions in the Intensive Care Unit in Adults With Respiratory Failure: A Randomised Clinical Feasibility Trial of Performing Versus Withholding Pleural Drainage
This trial evaluates the feasibility of ultrasound-guided pleural drainage versus no drainage in adult ICU patients with pleural effusions (fluid buildup around the lungs) and respiratory failure. Half of the patients will undergo drainage, while the other half will not unless their condition worsens to a prespecified degree. Outcomes include feasibility measures, clinical parameters, mortality, serious adverse events, and life support use over 90 days.
Read the detailed description
Pleural effusions are common in intensive care unit (ICU) patients and are often treated with fluid drainage guided by ultrasonography. While this can improve oxygenantion levels, it is unclear whether it leads to better overall outcomes, and the procedure carries risks such as bleeding or lung collapse. There is limited evidence and no randomised trials supporting this procedure in ICU patients with respiratory failure. The DOPE-ICU feasibility trial will assess the feasibility of evaluating pleural drainage in such patients. Eligible ICU patients will be randomly assigned to either receive drainage or no drainage unless their condition worsens to a prespecified degree. Feasibility outcomes include the proportion of patients receiving drainage, protocol adherence, and proportion of patients with consent withdrawal for follow-up. Clinical outcomes include death rates, serious adverse events, and life support use, all within 90 days. Process outcomes include oxygenation, pH and arterial carbon dioxide tension at prespecified time points. The trial aims to determine whether a larger, more definitive trial is feasible.
- Conditions
- Pleural Effusions, Respiratory Failure
- Being tested
- Ultrasonography-guided pleural drainage
- Keywords
- Pleural effusion, Respiratory failure, Pleural drainage, Ultrasonography, Intensive Care Unit, Randomised clinical trial, Feasibility, Critical care, Hypoxaemia, Hypercapnia
- Medical subject headings
- Pleural Effusion, Respiratory Insufficiency, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography-guided pleural drainageProcedure or surgery
Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter. Contralateral and repeated drainage conducted as specified during ICU stay until day 90.
| Study group | Role | What they receive |
|---|---|---|
| Pleural drainage | Experimental | Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter (typically pig-tail type catheter, size 6-14 French), conducted by e.g., intensivists or radiologists, as by local standards, of the pleural cavity with the estimated largest pleural effusion as soon as possible. A time interval of up to 24 hours from randomisation to intervention is expected. If bilateral pleural effusions ≥ 2 cm are present at randomisation, drainage of contralateral pleura should be conducted as soon as possible according to local standards, at least within 24 hours from insertion of the first pleural catheter unless pleural effusion has receded to < 2 cm prior to drainage. Inserted pleural catheters remain connected to a closed pleural drainage system, in situ and open until removed at clinicians' discretion according to local standards. New pleural effusion ≥ 2 cm during ICU stay within 90 days from randomisation will be drained similarly. Receives: Procedure: Ultrasonography-guided pleural drainage |
| No pleural drainage | No intervention | No pleural drainage is conducted during ICU stay in 90 days from randomisation, unless escape protocol criteria are present being suspected or confirmed haemothorax, suspected or confirmed pneumothorax, suspected or confirmed pleural empyema, suspected or confirmed pleural malignancy, or indication for therapeutic pleural drainage as per the treating clinician and invasive or non-invasive mechanical ventilation or mask CPAP with arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ratio ≤ 13.3 kPa in the most recent ABG analysis, high-flow humidified oxygen therapy with a flow ≥ 50 L/min and a PaO2/FiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis, or persistent respiratory acidosis with a pH < 7.25 and an arterial partial pressure of carbon dioxide (PaCO2) > 6.0 kPa on the most recent ABG analysis in spite of non-invasive ventilation for > 1 hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention group separation (feasibility)
Proportion of patients receiving pleural drainage during ICU stay
Measured: 90 days
Secondary outcomes (14)
Protocol adhearence (feasibility)
Proportion of patients with one or more protocol violations defined as:
- Participants allocated to pleural drainage who do not receive this within 24 hours from randomisation.
- Participants allocated to pleural drainage with bilateral pleural effusion who do not receive the second (contralateral) pleural drainage within 24 hours from the primary drainage, unless pleural effusion has receded < 2 cm.
- Participants allocated to no pleural drainage who receive pleural drainage at any time during ICU stay within 90 days from randomisation, including ICU readmissions, except when escape criteria for pleural drainage are present as specified (se "No intervention" arm).
Measured: 90 days
Recruitment proportion (feasibility)
Proportion of included patients out of the number of eligible patients, i.e., patients who comply with all inclusion and exclusion criteria
Measured: Through trial completion, estimated at 1 year.
Loss to follow-up (feasibility)
Proportion of participants without consent to the use of data
Measured: 90 days
All-cause mortality (clinical outcome)
All-cause mortality
Measured: 90 days
Serious adverse events (clinical outcome)
Proportion of patients with one or more serious adverse events (SAEs); SAEs are defined as new pneumothorax requiring invasive treatment (drainage or surgery), new haemothorax requiring red blood cell transfusion, new blood stream infection defined as any cultured microorganism from any blood sample except microorganisms clearly specified to be contaminants or likely contaminants by the microbiological department, and new episode of invasive mechanical ventilation defined as endotracheal intubation or re-intubation after extubation or tracheal decannulation.
Measured: 90 days
Days alive without life support (clinical outcome)
Absolute number of days alive without life support being the use of mechanical ventilation, renal replacement therapy, or circulatory support
Measured: 90 days
Days alive and out of hospital (clinical outcome)
Absolute number of days alive and out of hospital
Measured: 90 days
Pleural infections (process outcome)
Proportion of patients with new pleural infection after 24 hours from randomisation defined as any positive pleural fluid culture of any fungi or bacteria in any pleural fluid sampling conducted, except coagulase-negative Staphylococci, Enterococci, and Corynebacterium species, which will be considered contaminants.
Measured: After 24 hours and within 90 days from randomisation
24-hour oxygenation (process outcome)
PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Measured: 24 hours
72-hour oxygenation (process outcome)
PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Measured: 72 hours
24-hour pH (process outcome)
pH in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Measured: 24 hours
72-hour pH (process outcome)
pH in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Measured: 72 hours
24-hour carbon dioxide (process outcome)
PaCO2 in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Measured: 24 hours
72-hour carbon dioxide (process outcome)
PaCO2 in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start2 Dec 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionsStudies 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
- Parallel groups
- Model description
- Investigator-initiated, pragmatic, multicentre, open-label, randomised, parallel-group clinical feasibility trial
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olav Schjørring
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Olav Schjørring, Aalborg University Hospital
- Investigators
- Olav L Schjørring, MD, PhD, Principal investigator, Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709456
- Sponsor's protocol ID
- N-20240027
- Other IDs
- FID4401466, 2024-0049
- Status last verified
- Apr 2025
- First submitted
- 22 Nov 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All original records (incl. consent forms, eCRFs, and relevant correspondences) will be archived at trial sites for 15 years. Anonymised data can be shared after primary publication upon specific request to the DOPE-ICU feasibility trial Steering Committee.
Publications
Worm MS, Moller MH, Bruun NH, Brochner AC, Bestle MH, Rasmussen BS, Schjorring OL. Drainage of Pleural Effusion in the Intensive Care Unit (DOPE-ICU) Feasibility Trial-Protocol and Statistical Analysis Plan. Acta Anaesthesiol Scand. 2026 May;70(5):e70233. doi: 10.1111/aas.70233.
PubMed 41952333