Clinical trial NCT01130090: Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency
Official title: Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Non Invasive Ventilation
Lead sponsor: Ligue Pulmonaire Genevoise
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* OHS patients: unstable cardio-respiratory status and/or acute cardio-respiratory failure three months before inclusion.

Primary outcomes:
measure: Sleep structure
timeFrame: Night 1
measure: Sleep structure
timeFrame: Night 2
measure: Sleep structure
timeFrame: Night 3
Secondary outcomes:
measure: Transcutaneous capnography (PtcCO2)
timeFrame: Night 1
measure: Transcutaneous capnography (PtcCO2)
timeFrame: Night 2
measure: Transcutaneous capnography (PtcCO2)
timeFrame: Night 3
measure: Correlation between microarousal index and autonomic arousal index
timeFrame: Night 1
measure: Correlation between microarousal index and autonomic arousal index
timeFrame: Night 2
measure: Correlation between microarousal index and autonomic arousal index
timeFrame: Night 3
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University hospital - Sleep laboratory
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Paul Janssens, MD
role: STUDY_DIRECTOR
References:
citation: Georges M, Adler D, Contal O, Espa F, Perrig S, Pepin JL, Janssens JP. Reliability of Apnea-Hypopnea Index Measured by a Home Bi-Level Pressure Support Ventilator Versus a Polysomnographic Assessment. Respir Care. 2015 Jul;60(7):1051-6. doi: 10.4187/respcare.03633. Epub 2015 Mar 3.
citation: Contal O, Adler D, Borel JC, Espa F, Perrig S, Rodenstein D, Pepin JL, Janssens JP. Impact of different backup respiratory rates on the efficacy of noninvasive positive pressure ventilation in obesity hypoventilation syndrome: a randomized trial. Chest. 2013 Jan;143(1):37-46. doi: 10.1378/chest.11-2848.