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Neural Respiratory Drive in Pulmonary Hypertension

Neural Respiratory Drive in Pulmonary Hypertension

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04293640
Enrollment
120
Registered
2020-03-03
Start date
2019-02-01
Completion date
2021-01-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DIAGNOSTIC_TESTParasternal 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.

Sponsors

Golden Jubilee National Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patient is pregnant * Patient has a diagnosed neuromuscular disorder

Design outcomes

Primary

MeasureTime frameDescription
Change in neural respiratory drive3 monthsElectromyogram (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

MeasureTime frameDescription
Cross sectional assessment of neural respiratory driveBaseline testNovel data on levels of respiratory drive from parasternal EMG signals in patients with pulmonary hypertension

Countries

United Kingdom

Contacts

Primary ContactMartin Johnson
mjohnson4@nhs.net01419515000
Backup ContactPaul McCaughey
paulmccaughey@nhs.net07907029041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026