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

Launched by OLAV SCHJØRRING · Nov 25, 2024

Keywords

ClinConnect Summary

The DOPE-ICU trial is studying whether using ultrasound to guide the drainage of fluid around the lungs, known as pleural effusions, is effective for patients in the intensive care unit (ICU) who are also experiencing respiratory failure. In this trial, half of the participants will receive the drainage treatment, while the other half will not receive drainage unless their condition worsens significantly. The researchers will look at various outcomes, such as how feasible the drainage procedure is, overall health improvements, complications, and the need for life support over a 90-day period.

To be eligible for this trial, participants must be adults (18 years or older) who have been admitted to the ICU and have a pleural effusion of at least 2 cm. They also need to be experiencing respiratory failure, which may involve needing extra oxygen or mechanical breathing support. Patients with certain conditions, like ongoing bleeding in the chest or those who are pregnant, will not be eligible. Participants can expect close monitoring during the trial to assess their response to the treatment and overall health status. This study is an important step in understanding how best to manage pleural effusions in critically ill patients.

Gender

ALL

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.