Manometry vs Clinical Assessment in the Detection of Trapped Lung in Patients With Suspected Pleural Malignancy

NCT02805062 | Unknown

• 1 other identifier: GN16ON124
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

Malignant pleural effusion is a common clinical problem with median survival of approximately 6 months thus efficient management of Malignant pleural effusion is important. In patients with a Trapped Lung, pleurodesis will be unsuccessful and an indwelling pleural catheter should be inserted instead. Accurate detection of Trapped Lung prior to insertion would avoid futile attempts at talc pleurodesis, re-intervention following failed pleurodesis and allow adequate time to plan for an indwelling pleural catheter insertion.Pleural manometry allows direct and objective measurement of intra-pleural pressure during pleural fluid aspiration.The primary aim of this study is to determine whether the addition of digital pleural manometry to clinical judgment, prior to and during local anaesthetic thoracoscopy, results in a clinically meaningful improvement in Trapped Lung detection.

Conditions

Pleural Effusion, Malignant

Keywords

Trapped Lung

Outcome Measures

Primary Outcomes (3)

• Pleural Elastance

  Pleural elastance (change in pleural pressure divided by change in pleural volume), where trapped lung will be predicted by pleural elastance ≥ 14.5 cm pleural pressure.

  Single visit per subject

• Clinical judgement

  The clinical judgment of the Thoracoscopist as to the presence or absence of Trapped Lung

  Single visit per subject

• Trapped Lung

  Occurrence of trapped lung, defined as incomplete lung re-expansion on the pre-discharge chest radiograph after local anaesthetic thoracoscopy

  Single visit per subject

Secondary Outcomes (1)

• PEL-VOUT Agreement

  Single visit per subject

Study Arms (1)

Pleural Effusion

Malignant pleural effusion patients requiring investigation with thoracoscopy.

Procedure: Digital Pleural Manometry; Procedure: Magnetic Resonance Imaging

Interventions

Digital Pleural Manometry PROCEDURE

Measurement of intra-pleural pressure and the removal of pleural fluid.

Pleural Effusion

Magnetic Resonance Imaging PROCEDURE

Subject lies a long tunnel shaped scanner and images are recorded.

Also known as: MRI

Pleural Effusion

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

Patients with pleural effusion requiring further investigation with thoracoscopy.

You may qualify if:

• Informed written consent
• Suspected pleural malignancy requiring investigation by local anaesthetic thoracoscopy

You may not qualify if:

• Any contra-indication to local anaesthetic thoracoscopy
• Predicted pleural aspiration volume \< 1 litre, as defined by a maximum pleural fluid depth of \< 4 cm on thoracic ultrasound pre-aspiration
• Known contra-indication to MRI
• Previous attempt at talc pleurodesis
• Pregnancy
• Renal impairment (eGFR ≤ 30 ml/min)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Rocket Medical plc: collaborator

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Paul Dearie, BSc (HONS)

CONTACT

+44 (0)141 232 1810; paul.dearie@ggc.scot.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share