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

This study has been completed.
Sponsor:
Information provided by:
Ligue Pulmonaire Genevoise
ClinicalTrials.gov Identifier:
NCT01130090
First received: May 3, 2010
Last updated: February 23, 2011
Last verified: February 2011
May 3, 2010
February 23, 2011
September 2008
November 2010   (Final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01130090 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
Not Provided
Not Provided
 
Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency
Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Obesity
  • Non Invasive Ventilation
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01130090
CER- 08-131
Yes
Not Provided
Not Provided
Jean-Paul Janssens / Professor, Division of Pulmonary Diseases; Geneva University Hospital
Ligue Pulmonaire Genevoise
Not Provided
Study Director: Jean-Paul Janssens, MD Geneva University Hospital
Ligue Pulmonaire Genevoise
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP