Ventilator Monitoring in Early Exacerbation Detection

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Use of Ventilator Monitoring for Early Detection of Exacerbations of Chronic Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644162
• Other study ID #: 11/LO/1777
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: October 15, 2014
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2012
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing) in patients requiring long term home ventilation.

The investigators hypothesise that acute exacerbations of patients with respiratory disease and ventilatory failure will be predicted by changes in the respiratory variables monitored and stored by ventilators during chronic home ventilator use.

Description:

This pilot study is a proof of concept study investigating whether respiratory variables measured during chronic non-invasive ventilation (NIV) therapy may be used to predict a disease exacerbation.

Modern ventilators used in the home for chronic respiratory failure have the ability to monitor and store respiratory variables that may worsen during exacerbations, and may potentially detect exacerbations before symptoms become apparent. Normal pressure support ventilators monitor respiratory rate which might be expected to increase with worsening disease. In patients with obstructive airways disease an increase in expiratory time may potentially be observed with worsening airways obstruction. Adaptive servo ventilators, which modulate pressure support to maintain constant minute ventilation, may increase the amount of pressure support delivered if respiratory mechanics deteriorate as a result of an exacerbation.

Consenting experienced NIV users will be switched to an adaptive-servo ventilator with the capacity to monitor and store therapy data. The device being used is the Stellar 150 ventilator (Resmed, Ltd., Bella Vista, Australia) with hardware and software ability to measure variables such as respiratory rate, airflow, pressure support and leak.

Patients will use the ventilator for a total of 4 months during which they will complete daily symptom diaries, including medication use and peak flow measurements.

Changes in ventilator variables will be analysed and day to day variation identified. Changes will be compared with daily peak expiratory flow measures (an indication of how well the airways are functioning), patient symptoms, and healthcare utilization. Hospital admissions for exacerbations, GP consults, and healthcare team contacts will also be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of obstructive (COPD, cystic fibrosis, bronchiectasis or chronic asthma) or restrictive (NMD, chest wall disorder) lung disease confirmed by a hospital consultant

• aged > 18 years

• established home ventilator user with ventilator prescribed for either chronic ventilatory failure or nocturnal hypoventilation

• able to use bilevel positive pressure ventilation with Inspiratory positive airway pressure (IPAP) requirement <30cm H2O (Stellar ventilator - IPAP max 30)

Exclusion Criteria:

• patients < 18 years

• cognitive impairment sufficient to interfere with comprehension of the study or use of ventilator

• poor adherence with non-invasive ventilation (<3hours/night for >10days/month)

• Inspiratory positive airway pressure (IPAP) requirement >30cmH2O

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chest Wall Disorder
• Chronic Obstructive Pulmonary Disease
• Hypoventilation
• Lung Diseases, Obstructive
• Neuromuscular Disease
• Neuromuscular Diseases
• Obesity Hypoventilation Syndrome
• Pulmonary Disease, Chronic Obstructive
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• iVAPS ventilation
3 months of ventilation on iVAPS mode

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ventilator pressure support from baseline	Pressure Support delivered by the adaptive-servo ventilator at Day 0 of exacerbation compared to the pressure support during baseline stable state.	up to 3 months	No
Secondary	Changes in ventilator-measured parameters from baseline	Changes in ventilator-measured parameters >15% from baseline [respiratory rate (RR), inspiratory time (Ti), pressure support (PS), Minute volume (MV), tidal volume (Vt), flow, leak, oxygen saturation (SaO2), pulse, I:E ratio, apnoea-hypopnea index (AHI), compliance]	Up to 3 months	No
Secondary	Exacerbation as determined by a change in patients subjective symptoms	The presence of 2 or more subjective symptoms compared to baseline for 2 consecutive days; - breathlessness, increased sputum volume or sputum purulence, coryzal, wheeze or chest tightness, sore throat, cough, fever, sleep disruption, decreased physical activity	up to 3 months	No
Secondary	Change in peak expiratory flow rate (PEFR)>15% from baseline	Change in peak expiratory flow rate (PEFR)>15% from baseline	Up to 3 months	No
Secondary	Exacerbation as defined by healthcare utilisation	Exacerbation defined by the requirement of antibiotics +/- steroids, GP visit, accident and emergency visit, hospital admission	up to 3 months	No