Using Ultrasound to Predict the Results of Draining Pleural Effusions

NCT01973985 | Terminated

• 1 other identifier: PLMAN2013
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural effusion is an extremely common problem with multiple causes; its subsequent investigation with thoracocentesis and treatment with drainage represent two of the most frequently performed diagnostic and therapeutic medical procedures. The role of thoracic ultrasonography in the management of pleural effusion is a modern and rapidly expanding one, having become effectively mandatory and part of the "gold standard" over the past decade due to its diagnostic and patient safety benefits. By contrast, the measurement of intra-pleural pressure using sequential manometry has failed to convincingly demonstrate its clinical value beyond physiological studies despite its availability for over a century. Previous work has shown a potential role for pleural manometry in predicting the presence of un-expandable lung and success of talc pleurodesis but these studies have not been replicated or clinically validated. We intend to combine the old and new in an observational study comparing findings on thoracic ultrasonography and pleural manometry during thoracocentesis with patient-reported symptoms and the key clinical outcomes of presence of un-expandable lung and success of talc pleurodesis. The investigators hypothesise that the previously described variations in pleural elastance can be correlated with appearances and anatomical changes visualised on thoracic ultrasonography; and in combination can be reliably utilised to predict clinical outcome. The study may allow the proposal of a treatment algorithm that allows patients with pleural effusion to be managed in a more expeditious and efficient manner.

Conditions

Pleural Effusion

Keywords

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Diagnosis of unexpandable lung

  Clinical and/or radiological diagnosis of unexpandable lung

  Up to 3 months

Secondary Outcomes (2)

• Failure of talc pleurodesis

  3 months

• Absolute change in patient-reported symptoms

  Up to 3 months

Interventions

Pleural Manometry OTHER

Intrapleural pressure will be monitored with the use of an electronic pleural manometer (Mirador Biomedical CompassTM Thoracentesis Assist Device).

Thoracic ultrasonography OTHER

Thoracic ultrasound scan will be done before drainage of pleural effusion - all participants. Thoracic ultrasound scans will also be done during drainage of pleural effusion and the results will be recorded after every 100mL of pleural fluid drained - all participants. Thoracic ultrasound scan will be done after drainage of pleural effusion - all participants. Thoracic ultrasound scan will also be be done during clinic follow-up as part of routine clinical care - all participants.

Pleural aspiration catheter OR chest drain (standard care) PROCEDURE

Insertion of pleural aspiration catheter OR intercostal chest drain under ultrasound guidance - all participants (standard care).

Talc slurry pleurodesis via chest drain (standard care) PROCEDURE

Talc slurry pleurodesis via intercostal chest drain where/when clinically indicated as part of routine clinical care participants with intercostal chest drain only (standard care).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (\> or = 18 years old) undergoing large-volume diagnostic and/or therapeutic pleural aspiration or drainage for a symptomatic pleural effusion. (Large-volume aspiration or drainage will be defined as an expectation by the clinician responsible for assessing the patient that more than 500mL of pleural fluid is to be drained on this particular occasion).

You may qualify if:

• The participant is willing and able to give informed consent for participation in the study.
• Adult male or female, aged 18 years or above.
• Diagnosed with a symptomatic pleural effusion requiring either diagnostic and/or therapeutic pleural aspiration or drainage.
• Expectation by the clinician responsible for assessing the patient that more than 500mL of pleural fluid will be drained on this particular occasion.

You may not qualify if:

• Age less than 18 years
• Inability to provide informed consent
• Evidence of significant septation or loculation within the pleural effusion as determined by the clinician responsible for assessing the patient.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Pleural Effusion

Interventions

Chest Tubes; Standard of Care

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Najib Rahman, DPhil, MSc, MRCP

  University of Oxford & Oxford University Hospitals NHS Trust

  STUDY CHAIR

• John Corcoran, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: August 1, 2014
• Primary Completion: May 16, 2017
• Study Completion: May 16, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

GB (1)