Ventilator Monitoring in Early Exacerbation Detection
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|ClinicalTrials.gov Identifier: NCT01644162|
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : October 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Neuromuscular Disease Chest Wall Disorder Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome||Device: iVAPS ventilation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of Ventilator Monitoring for Early Detection of Exacerbations of Chronic Lung Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
3 months of ventilator use in iVAPS mode with data monitoring
Device: iVAPS ventilation
3 months of ventilation on iVAPS mode
Other Name: non-invasive ventilation
- Change in ventilator pressure support from baseline [ Time Frame: up to 3 months ]Pressure Support delivered by the adaptive-servo ventilator at Day 0 of exacerbation compared to the pressure support during baseline stable state.
- Changes in ventilator-measured parameters from baseline [ Time Frame: Up to 3 months ]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]
- Exacerbation as determined by a change in patients subjective symptoms [ Time Frame: up to 3 months ]
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
- Change in peak expiratory flow rate (PEFR)>15% from baseline [ Time Frame: Up to 3 months ]Change in peak expiratory flow rate (PEFR)>15% from baseline
- Exacerbation as defined by healthcare utilisation [ Time Frame: up to 3 months ]Exacerbation defined by the requirement of antibiotics +/- steroids, GP visit, accident and emergency visit, hospital admission
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644162
|Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Anita Simonds||Royal Brompton & Harefield NHS Foundation Trust|