Neural Respiratory Drive in Pulmonary Hypertension

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

Study Overview

• Status: Unknown
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: Parasternal electromyogram measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G81 4DY
    • Recruiting
    • Golden Jubilee National Hospital
    • Contact: Catherine Sinclair; Phone Number: 01419515000; Email: catherine.sinclair@gjnh.scot.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to Scottish Pulmonary Vascular Unit for investigation of pulmonary hypertension.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient is pregnant
• Patient has a diagnosed neuromuscular disorder

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in neural respiratory drive	Electromyogram (EMG) signals during tidal breathing as a proportion of EMG signals from maximal manoeuvre. Measured at baseline and again 3 months after commencing treatment.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross sectional assessment of neural respiratory drive	Novel data on levels of respiratory drive from parasternal EMG signals in patients with pulmonary hypertension	Baseline test

Collaborators and Investigators

• Sponsor: Golden Jubilee National Hospital
• Investigators: Principal Investigator: Martin Johnson, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 18/CARD/32

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