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New treatment option for Pleural Effusions
Official title Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial
ClinicalTrials.gov ID: NCT06709456
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Respiratory failure defined as one or more of the following: any oxygen supplementation in an open system, invasive or non-invasive mechanical...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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 \ 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...
- Under coercive measures (i.e., ongoing involuntary hospital admission or under correctional authorities' jurisdiction).
- Consent not obtainable as per Danish legislation.
- Previously assigned by chance in the DOPE-ICU feasibility trial.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Copenhagen, Denmark
- Hillerød, Denmark
- Kolding, Denmark
- Køge, Denmark
- Roskilde, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Copenhagen, Denmark; Hillerød, Denmark; Kolding, Denmark; Køge, Denmark; Roskilde, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.