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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
Sponsor:
Information provided by:
Ligue Pulmonaire Genevoise

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Non Invasive Ventilation Device: Adjustment of back-up respiratory rate on bi-level ventilator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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
Arms and Interventions
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Intervention Details:
  • Device: Adjustment of back-up respiratory rate on bi-level ventilator
    3 consecutive nights in randomized order, in either "S" (Spontaneous) mode, "ST" (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in "ST" (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort

Outcome Measures
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Primary Outcome Measures :
  1. Sleep structure [ Time Frame: Night 1 ]
    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

  2. Sleep structure [ Time Frame: Night 2 ]
    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

  3. Sleep structure [ Time Frame: Night 3 ]
    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)


Secondary Outcome Measures :
  1. Transcutaneous capnography (PtcCO2) [ Time Frame: Night 1 ]
    Mean PtcCO2 during Night 1

  2. Transcutaneous capnography (PtcCO2) [ Time Frame: Night 2 ]
    Mean PtcCO2 during night 2

  3. Transcutaneous capnography (PtcCO2) [ Time Frame: Night 3 ]
    Mean PtcCO2 during night 3

  4. 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)

  5. 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)

  6. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Geneva University hospital - Sleep laboratory
Geneva, Switzerland, 1211
Sponsors and Collaborators
Ligue Pulmonaire Genevoise
Investigators
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Study Director: Jean-Paul Janssens, MD University Hospital, Geneva
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jean-Paul Janssens / Professor, Division of Pulmonary Diseases; Geneva University Hospital
ClinicalTrials.gov Identifier: NCT01130090    
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