Using Ultrasound to Predict the Results of Draining Pleural Effusions

Correlation of Pleural Manometry With Real-time Thoracic Ultrasound, Symptomatic Benefit and Clinical Outcome in Patients With Pleural Effusion: a Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Pleural Effusion
• Intervention / Treatment: Other: Pleural Manometry; Other: Thoracic ultrasonography; Procedure: Pleural aspiration catheter OR chest drain (standard care); Procedure: Talc slurry pleurodesis via chest drain (standard care)

Detailed Description

Study-specific interventions will be the monitoring of intrapleural pressure using an electronic pleural manometer (Mirador Biomedical CompassTM Thoracentesis Assist Device) and thoracic ultrasonography. Both of these are considered non-invasive and low-risk to the study participants.

As part of their standard usual clinical care, participants will undergo a diagnostic and/or therapeutic pleural intervention in the form of thoracocentesis or pleural aspiration; intercostal chest drain insertion; and/or talc pleurodesis. All of these procedures are invasive and associated with potential complications that participants will be informed about as part of standard informed consent procedures. These interventions will however be clinically indicated and carried out whether or not an individual chooses to participate in this study. For those individuals who do participate in the study, any complications of these standard clinical care procedures will be recorded as part of the data collection process for the study.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of unexpandable lung	Clinical and/or radiological diagnosis of unexpandable lung	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of talc pleurodesis	Failure of talc pleurodesis (defined as the need for a further repeat pleural procedure for symptom relief within 3 months of attempted pleurodesis).	3 months
Absolute change in patient-reported symptoms	Absolute change in patient-reported symptoms (dyspnoea and chest discomfort) during pleural aspiration or drainage as measured using a visual analogue scale.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Study Chair: Najib Rahman, DPhil, MSc, MRCP, University of Oxford & Oxford University Hospitals NHS Trust; Principal Investigator: John Corcoran, MD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pleural Effusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: PLMAN2013