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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01130090
Study type Interventional
Source Ligue Pulmonaire Genevoise
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date November 2010

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