Ventilator Monitoring in Early Exacerbation Detection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01644162
First received: July 16, 2012
Last updated: October 15, 2014
Last verified: March 2012
  Purpose

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 Intervention
Respiratory Failure
Neuromuscular Disease
Chest Wall Disorder
Chronic Obstructive Pulmonary Disease
Obesity Hypoventilation Syndrome
Device: iVAPS ventilation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of Ventilator Monitoring for Early Detection of Exacerbations of Chronic Lung Disease

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Change in ventilator pressure support from baseline [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Pressure Support delivered by the adaptive-servo ventilator at Day 0 of exacerbation compared to the pressure support during baseline stable state.


Secondary Outcome Measures:
  • Changes in ventilator-measured parameters from baseline [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Change in peak expiratory flow rate (PEFR)>15% from baseline

  • Exacerbation as defined by healthcare utilisation [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Exacerbation defined by the requirement of antibiotics +/- steroids, GP visit, accident and emergency visit, hospital admission


Enrollment: 30
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
iVAPS ventilation
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644162

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Anita Simonds Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01644162     History of Changes
Other Study ID Numbers: 11/LO/1777
Study First Received: July 16, 2012
Last Updated: October 15, 2014
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by ResMed:
Non-Invasive Positive-Pressure Ventilation
Disease Exacerbation
Respiratory Failure

Additional relevant MeSH terms:
Hypoventilation
Lung Diseases
Lung Diseases, Obstructive
Neuromuscular Diseases
Obesity Hypoventilation Syndrome
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Apnea
Dyssomnias
Nervous System Diseases
Nutrition Disorders
Obesity
Overnutrition
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 29, 2014