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

Ligue Pulmonaire Genevoise

Status

Completed

Conditions

Non Invasive Ventilation

Obesity

Treatments

Device: Adjustment of back-up respiratory rate on bi-level ventilator

Study type

Interventional

Funder types

Other

Identifiers

NCT01130090

CER- 08-131

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Obesity-hypoventilation (OHS) patients, in stable clinical condition, treated with domiciliary nocturnal non invasive ventilation for at least two months

Exclusion criteria