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

ConditionsPleural EffusionsRespiratory Failure
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasonography-guided pleural drainage

    Procedure/Surgery

    Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter. Contralateral and repeated drainage conducted as specified during ICU stay until day 90.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Pleural drainageExperimental treatment 1 intervention
Group B: No pleural drainageNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intervention group separation (feasibility)

Proportion of patients receiving pleural drainage during ICU stay

Time frame
90 days

Secondary outcomes

1

Protocol adhearence (feasibility)

Proportion of patients with one or more protocol violations defined as: * Participants allocated to pleural drainage who do not receive this within 24 hours from randomisation. * Participants allocated to pleural drainage with bilateral pleural effusion who do not receive the second (contralateral) pleural drainage within 24 hours from the primary drainage, unless pleural effusion has receded \< 2 cm. * Participants allocated to no pleural drainage who receive pleural drainage at any time during ICU stay within 90 days from randomisation, including ICU readmissions, except when escape criteria for pleural drainage are present as specified (se "No intervention" arm).

Time frame
90 days
2

Recruitment proportion (feasibility)

Proportion of included patients out of the number of eligible patients, i.e., patients who comply with all inclusion and exclusion criteria

Time frame
Through trial completion, estimated at 1 year.
3

Loss to follow-up (feasibility)

Proportion of participants without consent to the use of data

Time frame
90 days
4

All-cause mortality (clinical outcome)

All-cause mortality

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olav Schjørring

Lead sponsor

Aalborg University Hospital

Sponsor institution

Rigshospitalet, Denmark

Collaborator

Source ClinicalTrials.gov
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