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NRD to Predict COPD Exacerbations at Home

NCT03443505 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2019-10-17

No results posted yet for this study

Summary

COPD is a common, serious disease and is a major burden on patients and the National Health Service. Patients with COPD can develop worsening of their symptoms, known as an exacerbation, which can be severe enough to warrant hospital admission. There are currently no objective measurements available to patients and clinicians to predict exacerbation and monitor recovery. Detection of exacerbation by both patients and physicians is known to correlate poorly with onset of respiratory deterioration.

Measurement of neural respiratory drive (NRD), or drive to breathe, using respiratory muscle electromyography (EMG) correlates with changes in patients' symptoms and physician defined deterioration during hospital admissions.

This pilot study aims to identify whether daily measurement of NRD at home following admission to hospital with exacerbation of COPD can detect an exacerbation within 30 days of discharge (20% of patients are readmitted within this period). This technique could enable early detection of deterioration at home, facilitating earlier treatment compared to current practice, potentially avoiding hospital readmission.

30 patients admitted to St Thomas' Hospital because of an exacerbation of COPD aged 40-80, with a body mass index \<35kg/m2, who can follow English instructions and give informed consent, who are discharged home will be recruited. If patients consent to participate, they will have assessments as inpatients and for 30 days at home following discharge, or until hospital readmission, whichever is sooner. Assessments include vital observations (heart rate, blood pressure, respiratory rate and oxygen saturations), NRD, and a symptom questionnaire. At the baseline assessment, age, height weight, a brief medical history, results of tests already taken by the clinical team (blood tests and chest x-ray) and lung function tests will be recorded. This study will take 12 months. Philips and its Affiliates are providing the NRD measuring equipment.

Conditions

Interventions

DIAGNOSTIC_TEST

Neural respiratory drive measurement

Neural respiratory drive (NRD) has been validated as an objective physiological biomarker in acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Change in NRD during hospital admission has been demonstrated to be a marker of physician-defined clinical deterioration. NRD is a non-invasive measurement that involves skin preparation with a gel and alcohol wipe before placing 3 surface electrodes on the chest wall and collar bone to perform electromyography (EMG) of parasternal muscles. Electrodes are connected to an automated EMG analysis system to derive a measurement of NRD. Measurements take approximately 10 minutes with subject being monitored during normal ("tidal") breathing and performing maximal sniff manoeuvres.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nicholas Hart, MBBSPhDFFICM · Guy's and St Thomas' NHS Foundation Trust

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2019-06-06
Completion
2019-06-06

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443505 on ClinicalTrials.gov