Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlav Schjørring
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Ultrasonography-guided pleural drainage
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Olav Schjørring
Lead sponsor
Aalborg University Hospital
Sponsor institution
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov