Ventilator Monitoring in Early Exacerbation Detection

NCT01644162 | Completed

• 1 other identifier: 11/LO/1777
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Neuromuscular Disease; Chest Wall Disorder; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome

Keywords

Non-Invasive Positive-Pressure Ventilation; Disease Exacerbation; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in ventilator-measured parameters from baseline

  Up to 3 months

• Exacerbation as determined by a change in patients subjective symptoms

  up to 3 months

• Change in peak expiratory flow rate (PEFR)>15% from baseline

  Up to 3 months

• Exacerbation as defined by healthcare utilisation

  up to 3 months

Study Arms (1)

iVAPS ventilation

OTHER

3 months of ventilator use in iVAPS mode with data monitoring

Device: iVAPS ventilation

Interventions

iVAPS ventilation DEVICE

3 months of ventilation on iVAPS mode

Also known as: non-invasive ventilation

iVAPS ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Neuromuscular Diseases; Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome; Disease Progression

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Hypoventilation; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Anita Simonds

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 17, 2014

Record last verified: 2012-03

Locations

GB (1)