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Using Ultrasound to Predict the Results of Draining Pleural Effusions

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ClinicalTrials.gov Identifier: NCT01973985
Recruitment Status : Terminated (Difficult to recruit to due to conflicting trials recruiting similar participants.)
First Posted : November 1, 2013
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date October 25, 2013
First Posted Date November 1, 2013
Last Update Posted Date January 10, 2018
Actual Study Start Date August 1, 2014
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2013)
Diagnosis of unexpandable lung [ Time Frame: Up to 3 months ]
Clinical and/or radiological diagnosis of unexpandable lung
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01973985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 25, 2013)
  • Failure of talc pleurodesis [ Time Frame: 3 months ]
    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 ]
    Absolute change in patient-reported symptoms (dyspnoea and chest discomfort) during pleural aspiration or drainage as measured using a visual analogue scale.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Using Ultrasound to Predict the Results of Draining Pleural Effusions
Official Title Correlation of Pleural Manometry With Real-time Thoracic Ultrasound, Symptomatic Benefit and Clinical Outcome in Patients With Pleural Effusion: a Pilot Study
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.

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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
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).
Condition Pleural Effusion
Intervention
  • 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).
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 8, 2018)
2
Original Estimated Enrollment
 (submitted: October 25, 2013)
50
Actual Study Completion Date May 16, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01973985
Other Study ID Numbers PLMAN2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators Not Provided
Investigators
Study Chair: Najib Rahman, DPhil, MSc, MRCP University of Oxford & Oxford University Hospitals NHS Trust
Principal Investigator: John Corcoran, MD University of Oxford
PRS Account University of Oxford
Verification Date January 2018