Ventilator Monitoring in Early Exacerbation Detection

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Respiratory Failure; Obesity Hypoventilation Syndrome; Neuromuscular Disease; Chest Wall Disorder
• Intervention / Treatment: Device: iVAPS ventilation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: iVAPS ventilation; 3 months of ventilator use in iVAPS mode with data monitoring	Device: iVAPS ventilation; 3 months of ventilation on iVAPS mode; Other Names: non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in peak expiratory flow rate (PEFR)>15% from baseline	Change in peak expiratory flow rate (PEFR)>15% from baseline	Up to 3 months
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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Anita Simonds, Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (ESTIMATE): July 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Respiratory Failure; Disease Exacerbation; Non-Invasive Positive-Pressure Ventilation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: 11/LO/1777