Using Ultrasound to Predict the Results of Draining Pleural Effusions

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01973985
First received: October 25, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Pleural Effusion
Other: Pleural Manometry
Other: Thoracic ultrasonography
Procedure: Pleural aspiration catheter OR chest drain (standard care)
Procedure: Talc slurry pleurodesis via chest drain (standard care)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Correlation of Pleural Manometry With Real-time Thoracic Ultrasound, Symptomatic Benefit and Clinical Outcome in Patients With Pleural Effusion: a Pilot Study

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Diagnosis of unexpandable lung [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Clinical and/or radiological diagnosis of unexpandable lung


Secondary Outcome Measures:
  • Failure of talc pleurodesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Failure of talc pleurodesis (defined as the need for a further repeat pleural procedure for symptom relief within 3 months of attempted pleurodesis).

  • Absolute change in patient-reported symptoms [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Absolute change in patient-reported symptoms (dyspnoea and chest discomfort) during pleural aspiration or drainage as measured using a visual analogue scale.


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Pleural Manometry
    Intrapleural pressure will be monitored with the use of an electronic pleural manometer (Mirador Biomedical CompassTM Thoracentesis Assist Device).
    Other: Thoracic ultrasonography

    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.

    Procedure: Pleural aspiration catheter OR chest drain (standard care)
    Insertion of pleural aspiration catheter OR intercostal chest drain under ultrasound guidance - all participants (standard care).
    Procedure: Talc slurry pleurodesis via chest drain (standard care)
    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).
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973985

Contacts
Contact: John Corcoran, MD 01865857086 jpcorcoran@doctors.org.uk
Contact: Magda Laskawiec-Szkonter, MA 01865225205 magda.laskawiec@ouh.nhs.uk

Locations
United Kingdom
Churchill Hospital Not yet recruiting
Oxford, United Kingdom, OX3 7LE
Principal Investigator: John Corcoran, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01973985     History of Changes
Other Study ID Numbers: PLMAN2013
Study First Received: October 25, 2013
Last Updated: June 3, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Pleural Effusion

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014