Neural Respiratory Drive in Pulmonary Hypertension

NCT ID: NCT04293640

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-01-31

Brief Summary

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Investigating neural respiratory drive by examining parasternal EMG measurements in patients presenting for assessment of presumed pulmonary hypertension.

Detailed Description

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NRD can be assessed by measuring parasternal electromyogram (EMG). Readings are taken by applying two small electrodes in the second intercostal space either side of the sternum and one to the shoulder. The electrodes are similar to those used in ECG acquisition. Measurements are then taken during normal breathing and also during maximal breathing effort ('sniff' procedure). Tests may be taken with patient recumbent at 45 degrees and supine. The test is non-invasive, has been safely performed in patients in previous studies and is not anticipated to cause any harm or distress. The total time for measurements will be around 20 minutes per patient.

NRD will be calculated as root mean square of normal tidal breathing as a proportion of maximal inspiratory effort (maximum inspiration from functional reserve capacity, taken as a sniff manoeuvre). Measurements will be performed in a ward based setting at the patient's bedside.

At the end of the inpatient stay for diagnosis, some patients are commenced on treatment and followed up in clinic. It would be the intention of the investigators to reassess these patients at clinic to test NRD and compare how this changes over time compared to other clinical parameters.

In addition, we will collect further readings of NRD in these patients when they attend for their standard follow up appointment. For the majority of patients, this will be after 3-4 months. For a subset of patients with chronic thromboembolic pulmonary hypertension, this may be up to one year after initial readings because these patients may be suitable for surgical intervention, which is not done locally and usually takes place 6-12 months after diagnosis at SPVU.

As such, the investigators intend that a patient will take part in the study for 52 weeks maximum, with most patients taking part for 16 weeks, and the study will not require them to have any additional attendances at hospital outwith their standard hospital admission for diagnosis and clinic follow up.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Parasternal electromyogram measurement

Three electrodes are applied to the chest (two to parasternal muscles, one reference electrode to clavicle). Measurements of EMG signals are recorded on appropriate software.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Able to give informed consent
* Being investigated for pulmonary hypertension

Exclusion Criteria

* Patient is pregnant
* Patient has a diagnosed neuromuscular disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Johnson

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

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Golden Jubilee National Hospital

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Martin Johnson

Role: CONTACT

01419515000

Paul McCaughey

Role: CONTACT

07907029041

Facility Contacts

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Catherine Sinclair

Role: primary

01419515000

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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18/CARD/32

Identifier Type: -

Identifier Source: org_study_id

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