Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Pleural Effusions
• Intervention / Treatment: Procedure: Ultrasonography-guided pleural drainage

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie S Worm, MD; Phone Number: +45 97 66 19 24; Email: marie.worm@rn.dk
• Study Contact Backup: Name: Olav L Schjørring, MD, PhD; Phone Number: +45 97 66 19 21; Email: o.schjoerring@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Department of Anaesthesia and Intensive Care, Aalborg University Hospital
    • Contact: Marie S Worm, MD; Phone Number: +45 97 66 19 24; Email: marie.worm@rn.dk
    • Contact: Olav L Schjørring, MD, PhD; Phone Number: +45 97 66 19 21; Email: o.schjoerring@rn.dk
  • Copenhagen, Denmark, 2100
    • Recruiting
    • ICU department 4131, Copenhagen University Hospital, Rigshospitalet
    • Contact: Morten H Møller, MD, PhD; Phone Number: +45 35 45 86 85; Email: morten.hylander.moeller@regionh.dk
  • Hillerød, Denmark, 3400
    • Recruiting
    • Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
    • Contact: Morten H Bestle, MD, PhD; Phone Number: +45 48 29 20 17; Email: morten.bestle@regionh.dk
  • Kolding, Denmark, 6000
    • Recruiting
    • Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
    • Contact: Anne C Brøchner, MD, PhD; Phone Number: +45 76 36 31 14; Email: anne.craveiro.broechner@rsyd.dk
  • Køge, Denmark, 4600
    • Not yet recruiting
    • Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
    • Contact: Lars PK Andersen, MD, PhD; Phone Number: +45 56 63 15 00; Email: lapan@regionsjaelland.dk
  • Roskilde, Denmark, 4000
    • Not yet recruiting
    • Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
    • Contact: Henrik P Pedersen, MD; Phone Number: +45 46 32 32 00; Email: hppd@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pleural drainage; 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.	Procedure: Ultrasonography-guided pleural drainage; 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.
No Intervention: No pleural drainage; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention group separation (feasibility)	Proportion of patients receiving pleural drainage during ICU stay	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	Through trial completion, estimated at 1 year.
Loss to follow-up (feasibility)	Proportion of participants without consent to the use of data	90 days
All-cause mortality (clinical outcome)	All-cause mortality	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.	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	90 days
Days alive and out of hospital (clinical outcome)	Absolute number of days alive and out of hospital	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.	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.	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.	72 hours
24-hour pH (process outcome)	pH in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.	24 hours
72-hour pH (process outcome)	pH in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.	72 hours
24-hour carbon dioxide (process outcome)	PaCO2 in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.	24 hours
72-hour carbon dioxide (process outcome)	PaCO2 in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.	72 hours

Collaborators and Investigators

• Sponsor: Olav Schjørring
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Olav L Schjørring, MD, PhD, Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Intensive Care Unit; Critical care; Ultrasonography; Respiratory failure; Hypercapnia; Pleural effusion; Randomised clinical trial; Hypoxaemia; Pleural drainage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Pleural Diseases; Respiratory Insufficiency; Pleural Effusion
• Other Study ID Numbers: N-20240027; FID4401466 (Other Grant/Funding Number: Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' legat); 2024-0049 (Other Grant/Funding Number: Region Nordjyllands Sundhedsvidenskabelige Forskningsfond)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Study protocol with statistical analysis plan and informed consent forms are available on the webpage (www.cric.nu/dope-icu)
• IPD Sharing Access Criteria: Managed by the Steering Committee of the DOPE-ICU feasibility trial.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No