Evaluating ultrasound-guided pleural drainage in ICU patients with respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial assesses the feasibility of performing ultrasound-guided pleural drainage in adult ICU patients suffering from pleural effusions and respiratory failure. Participants will be randomly assigned to either receive drainage or not, unless their condition deteriorates. The study will measure various outcomes, including the proportion of patients receiving drainage, adherence to the protocol, and clinical outcomes such as mortality and serious adverse events over a 90-day period. The aim is to determine if a larger, definitive trial on this intervention is feasible.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Anaesthesia and Intensive Care, Aalborg University Hospital
  Aalborg, Denmark Recruiting
• ICU department 4131, Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
  Hillerød, Denmark Recruiting
• Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
  Kolding, Denmark Recruiting
• Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
  Køge, Denmark Not yet recruiting
• Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
  Roskilde, Denmark Not yet recruiting

Study contacts

• Principal investigator: Olav L Schjørring, MD, PhD — Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark
• Study coordinator: Marie S Worm, MD
• Email: marie.worm@rn.dk
• Phone: +45 97 66 19 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.