Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency
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ClinicalTrials.gov Identifier: NCT01130090 |
Recruitment Status
:
Completed
First Posted
: May 25, 2010
Last Update Posted
: February 24, 2011
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Non Invasive Ventilation | Device: Adjustment of back-up respiratory rate on bi-level ventilator | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |
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Device: Adjustment of back-up respiratory rate on bi-level ventilator
- Sleep structure [ Time Frame: Night 1 ]Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)
- Sleep structure [ Time Frame: Night 2 ]Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)
- Sleep structure [ Time Frame: Night 3 ]Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)
- Transcutaneous capnography (PtcCO2) [ Time Frame: Night 1 ]Mean PtcCO2 during Night 1
- Transcutaneous capnography (PtcCO2) [ Time Frame: Night 2 ]Mean PtcCO2 during night 2
- Transcutaneous capnography (PtcCO2) [ Time Frame: Night 3 ]Mean PtcCO2 during night 3
- Correlation between microarousal index and autonomic arousal index [ Time Frame: Night 1 ]Correlation between microarousal index (assessed by EEG) and autonomic arousal index under NIV (assessed by pulse plethysmography)
- Correlation between microarousal index and autonomic arousal index [ Time Frame: Night 2 ]Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)
- Correlation between microarousal index and autonomic arousal index [ Time Frame: Night 3 ]Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130090
Switzerland | |
Geneva University hospital - Sleep laboratory | |
Geneva, Switzerland, 1211 |
Study Director: | Jean-Paul Janssens, MD | Geneva University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jean-Paul Janssens / Professor, Division of Pulmonary Diseases; Geneva University Hospital |
ClinicalTrials.gov Identifier: | NCT01130090 History of Changes |
Other Study ID Numbers: |
CER- 08-131 |
First Posted: | May 25, 2010 Key Record Dates |
Last Update Posted: | February 24, 2011 |
Last Verified: | February 2011 |