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Clinical Trials/NCT04293640
NCT04293640
Unknown
Not Applicable

Neural Respiratory Drive in Pulmonary Hypertension

Golden Jubilee National Hospital1 site in 1 country120 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Golden Jubilee National Hospital
Enrollment
120
Locations
1
Primary Endpoint
Change in neural respiratory drive
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
January 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patient is pregnant
  • Patient has a diagnosed neuromuscular disorder

Outcomes

Primary Outcomes

Change in neural respiratory drive

Time Frame: 3 months

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.

Secondary Outcomes

  • Cross sectional assessment of neural respiratory drive(Baseline test)

Study Sites (1)

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