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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
RECRUITING
Aalborg
ICU department 4131, Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
RECRUITING
Hillerød
Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
NOT_YET_RECRUITING
Køge
Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
RECRUITING
Kolding
Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
NOT_YET_RECRUITING
Roskilde
Contact Information
Primary
Marie S Worm, MD
marie.worm@rn.dk
+45 97 66 19 24
Backup
Olav L Schjørring, MD, PhD
o.schjoerring@rn.dk
+45 97 66 19 21
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2025-10
Participants
Target number of participants: 88
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Olav Schjørring
Collaborators: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov