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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or above

Has a unilateral pleural effusion AND

require thoracocentesis OR

chest drain insertion (main study only) OR

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surface parasternal eletromyogram

    Other intervention

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

  • Surface diaphragm electromyogram

    Other intervention

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

  • Parasternal muscle ultrasound

    Other intervention

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

  • Breathlessness assessment

    Other intervention

    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

Treatment groups

124 Participants
are divided into 1 treatment group
Group A: Symptomatic pleural effuion4 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
24 hours
2

Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal

VAS dyspnoea score

Time frame
24 hours

Secondary outcomes

1

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

Neural respiratory drive index (as measured by surface parasternal EMG)

Time frame
pre procedure, immediately post procedure and daily up to 7 days
2

Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal

VAS dyspnoea score

Time frame
pre procedure, immediately post procedure and daily up to and 7 days
3

The effect on exercise capacity of pleural fluid removal.

6 min walk test

Time frame
pre procedure, immediately post procedure, 1 day and 7 days
4

Pleural effusion characteristics as measured by thoracic ultrasound

Thoracic ultrasound

Time frame
immediately post procedure, 1 day and 7 days

Other outcomes

Sponsors and contacts

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