Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)

February 27, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust

Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)

The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will involve 124 adult patients who are breathlessness with pleural effusions. They will be recruited from a single UK centre over an 18-month period.

After being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. The investigators will record information about them and their disease. The investigators will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. These will be taken at the start and end of drainage, as well as 1 day and 7 days after. The investigators will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients' breathlessness.

Study Type

Observational

Enrollment (Estimated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.

Description

Inclusion Criteria:

  • Age 18 years or above

  • Has a unilateral pleural effusion AND

    1. require thoracocentesis OR
    2. chest drain insertion (main study only) OR
    3. has an IPC in situ (main study only)

Exclusion Criteria:

  • Inability to consent
  • Any contraindications to the proposed pleural procedure
  • Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements
  • Inability to identify surface landmarks for surface EMG electrode placement
  • Past medical history of diaphragmatic paralysis (diaphragm sub study only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic pleural effuion
Patients with symptomatic unilateral pleural effusion of any cause who will be undergoing pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for relief of their breathlessness.
Other: Surface parasternal eletromyogram
The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
Other: Surface diaphragm electromyogram
The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
Other: Parasternal muscle ultrasound
The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
Other: Breathlessness assessment
The VAS breathlessness score and Dyspnoea-12 questionnaire of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal
Time Frame: 24 hours
Neural respiratory drive index (as measured by surface parasternal EMG)
24 hours
Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
Time Frame: 24 hours
VAS dyspnoea score
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal
Time Frame: pre procedure, immediately post procedure and daily up to 7 days
Neural respiratory drive index (as measured by surface parasternal EMG)
pre procedure, immediately post procedure and daily up to 7 days
Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal
Time Frame: pre procedure, immediately post procedure and daily up to and 7 days
VAS dyspnoea score
pre procedure, immediately post procedure and daily up to and 7 days
The effect on exercise capacity of pleural fluid removal.
Time Frame: pre procedure, immediately post procedure, 1 day and 7 days
6 min walk test
pre procedure, immediately post procedure, 1 day and 7 days
Pleural effusion characteristics as measured by thoracic ultrasound
Time Frame: immediately post procedure, 1 day and 7 days
Thoracic ultrasound
immediately post procedure, 1 day and 7 days
To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians
Time Frame: peri-procedural
Qualitative feedback form
peri-procedural
Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis
Time Frame: peri-procedural
Neural respiratory drive index (as measured by surface diaphragm EMG)
peri-procedural
Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
Time Frame: peri-procedural
Thoracic ultrasound
peri-procedural
Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis
Time Frame: peri-procedural
Neural respiratory drive index (as measured by surface diaphragm EMG)
peri-procedural
Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
Time Frame: peri-procedural
Thoracic ultrasound
peri-procedural
Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal
Time Frame: peri-procedural
Thoracic ultrasound
peri-procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Patrick Murphy, MBBS BSc, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 322762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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