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

Not Applicable

Completed

• Conditions: Obesity; Non Invasive Ventilation

• Registration Number: NCT01130090
• Lead Sponsor: Ligue Pulmonaire Genevoise

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep structure	Night 3	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

Secondary Outcome Measures

Name	Time	Method
Transcutaneous capnography (PtcCO2)	Night 3	Mean PtcCO2 during night 3
Correlation between microarousal index and autonomic arousal index	Night 3	Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)

Trial Locations

Locations (1)

Geneva University hospital - Sleep laboratory; 🇨🇭 Geneva, Switzerland