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

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 study is testing if using ultrasound to help drain fluid from the lungs can improve the health of adults in the ICU who are struggling to breathe.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aalborg University Hospital (other)
• Locations: 6 sites (Aalborg and 5 other locations)
• Trial ID: NCT06709456 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with pleural effusions of at least 2 cm and respiratory failure.

Not a fit: Patients with existing pleural drains, suspected or confirmed haemothorax, or pneumothorax may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of pleural drainage in improving outcomes for ICU patients with respiratory failure.

How similar studies have performed: There is limited evidence and no prior randomized trials specifically addressing this intervention in ICU patients with respiratory failure, making this approach relatively novel.

Eligibility criteria

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 this trial is running

Aalborg and 5 other locations

• 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

Conditions: Pleural Effusions, Respiratory Failure, Pleural effusion, Respiratory failure, Pleural drainage, Ultrasonography, Intensive Care Unit, Randomised clinical trial