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

NCT05945043 | Recruiting

• 1 other identifier: 322762
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion

Keywords

Pleural effusion; Breathlessness; Neural respiratory drive; Neurophysiology

Outcome Measures

Primary Outcomes (2)

• Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal

  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

  VAS dyspnoea score

  24 hours

Secondary Outcomes (10)

• Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal

  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

  pre procedure, immediately post procedure and daily up to and 7 days

• The effect on exercise capacity of pleural fluid removal.

  pre procedure, immediately post procedure, 1 day and 7 days

• Pleural effusion characteristics as measured by 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

  peri-procedural

Study Arms (1)

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; Other: Surface diaphragm electromyogram; Other: Parasternal muscle ultrasound; Other: Breathlessness assessment

Interventions

Surface parasternal eletromyogram OTHER

The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal

Symptomatic pleural effuion

Surface diaphragm electromyogram OTHER

The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal

Symptomatic pleural effuion

Parasternal muscle ultrasound OTHER

The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal

Symptomatic pleural effuion

Breathlessness assessment OTHER

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

Symptomatic pleural effuion

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

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

You may qualify if:

• Age 18 years or above
• Has a unilateral pleural effusion AND
• require thoracocentesis OR
• chest drain insertion (main study only) OR
• has an IPC in situ (main study only)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, London, SE1 9RT, United Kingdom

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Pleural Effusion; Dyspnea

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Murphy, MBBS BSc

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junyi Zhang, MBBChir

CONTACT

02071887188; junyi.zhang@gstt.nhs.uk

Gillian Radcliffe

CONTACT

02071888070; gillian.radcliffe@gstt.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 7, 2023
• First Posted: July 14, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)