Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation

NCT00479284 | Completed

• 1 other identifier: Protocol 06-094
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic hypercapnic respiratory failure can be successfully treated with home nocturnal non-invasive ventilation. Bi-level pressure support ventilators are at present the most frequently used ventilators for long term home ventilation. A recently commercialized bi-level ventilator offers the feature of automatically adjusting pressure support on the basis of a pre-determined ideal effective ventilation. Because this option may induce important swings in pressure support, and thus patient discomfort, and maybe increase leaks, we chose to analyse the impact of average volume assured pressure support (AVAPS) on patient comfort, subjective and objective quality of sleep and efficacy of ventilatory support.

Conditions

Chronic Hypercapnic Respiratory Failure; Obesity Hypoventilation Syndrome; Chronic Obstructive Pulmonary Disease

Keywords

Non-invasive ventilation; Polysomnography; Average volume assured pressure support

Outcome Measures

Primary Outcomes (2)

• Quality of sleep

  One night

• Efficacy of ventilation

  One night

Secondary Outcomes (1)

• Patient comfort

  One night

Interventions

Average volume assured pressure support (AVAPS) PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated for chronic hypercapnic respiratory failure by home bi-level positive pressure non-invasive ventilation for at least 3 months, in a stable clinical condition

You may not qualify if:

• Poor compliance (\< 4 hours/day) to home ventilation or recent episode ( \< 3 months) of cardiac or respiratory failure necessitating hospitalization

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Ligue Pulmonaire Genevoise: collaborator

Study Sites (1)

Sleep Laboratory; Department of Psychiatry, Geneva University Hospital

Chêne-Bourg, Canton of Geneva, 1225, Switzerland

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Paul Janssens, M.D.

  Division of Lung Diseases, Department of Medicine, Geneva University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: May 28, 2007

Record last verified: 2007-05

Locations

CH (1)