NRD to Predict COPD Exacerbations at Home

NCT03443505 | Completed

• 1 other identifier: 232384
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Acute exacerbation; Neural respiratory drive; Parasternal electromyography; Respiratory physiology; Lung function

Outcome Measures

Primary Outcomes (1)

• Change in NRD from baseline to day prior to an acute exacerbation of COPD.

  Change in EMGpara%max (derived from RMS EMGpara and maximal sniff manoevres) from subjects' baseline NRD to the day before a clinical re-exacerbation of COPD following index hospitalisation with AECOPD.

  30 days

Secondary Outcomes (12)

• Change in NRD from peak exacerbation (hospital) to recovery baseline (home)

  30 days

• Correlation of time to recovery as measured by NRD and EXACT-PRO

  30 days

• Correlation of NRD to EXACT-PRO from hospital discharge to recovery

  30 days

• Correlation of NRD to physical activity from hospital discharge to recovery

  30 days

• Physician-assessed exacerbation within 30-day post-discharge

  30 days

Interventions

Neural respiratory drive measurement DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with a primary diagnosis of an acute exacerbation of COPD.

You may qualify if:

• Age 40-80 years
• Patients hospitalized with a primary diagnosis of an acute exacerbation of COPD
• Body mass index (BMI) ≤ 35 kg/m2
• Cognitively and linguistically able to follow instructions given in English and provide informed consent
• To be discharged to home following the hospitalization
• Patient lives in the catchment area served by the Integrated Respiratory Team at Guy's and St Thomas' NHS Foundation Trust in a home environment deemed safe by the investigators to perform home assessments

You may not qualify if:

• Previous home PAP (CPAP or NIV) therapy use within the past year, or post-discharge
• Allergies to latex, metals or local anaesthetic agents
• Wound or inflamed skin at parasternal location (2nd intercostal space)
• History of skin allergies or sensitivity to cosmetics and lotions
• Psychological and social factors that would impair compliance with study protocol and schedule
• Any major non-COPD chronic disease or condition, such as severe heart failure (LVEF\<30%), malignancy (active treatment and palliation), end stage renal failure/dialysis, significant neuromuscular disease (e.g. NMD, MD) determined by review of medical history and / or patient reported medical history that may contribute significantly to risk of readmission, as determined by PI
• Length of stay ≤ 24 hours
• Planned travel away from home within the 30 day post discharge period

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Hart, MBBSPhDFFICM

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 23, 2018
• Study Start: February 13, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)