NCT01130090

Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency

Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ligue Pulmonaire Genevoise · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use * Spontaneous mode (S) * Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the respiratory rate of the patient * Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue has to our knowledge only been marginally studied without any consensus.

Detailed description

Eligibility: patients under home bi-level pressure support ventilation for obesity hypoventilation in a stable clinical condition, aged over 18 Methods: Three consecutive sleep studies in a randomised sequence with usual parameters Inspiratory Positive Airway Pressure(IPAP), Expiratory Positive Airway Pressure (EPAP) and change of only back up respiratory rate (RR): one night in a spontaneous mode, one with an intermediate RR, and one with a RR above that of the patient Endpoints: Quality of sleep and sleep structure (polysomnography), patient-ventilator synchronisation and respiratory events under NIV, efficacy of ventilation: oxygen saturation measured by pulse oxymetry (SaO2); transcutaneous capnography (PtcCO2), and comfort.

Conditions

• Obesity
• Non Invasive Ventilation

Interventions

Type	Name	Description
DEVICE	Adjustment of back-up respiratory rate on bi-level ventilator	3 consecutive nights in randomized order, in either "S" (Spontaneous) mode, "ST" (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in "ST" (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-05-25
• Last updated: 2011-02-24

Locations

1 site across 1 country: Switzerland