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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
History of Changes
  Purpose

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 Intervention
Obesity
Non Invasive Ventilation
 Device: Adjustment of back-up respiratory rate on bi-level ventilator

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency

Further study details as provided by Ligue Pulmonaire Genevoise:

Primary Outcome Measures:
  • Sleep structure [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

  • Sleep structure [ Time Frame: Night 2 ] [ Designated as safety issue: No ]
    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

  • Sleep structure [ Time Frame: Night 3 ] [ Designated as safety issue: No ]
    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)


Secondary Outcome Measures:
  • Transcutaneous capnography (PtcCO2) [ Time Frame: Night 1 ] [ Designated as safety issue: Yes ]
    Mean PtcCO2 during Night 1

  • Transcutaneous capnography (PtcCO2) [ Time Frame: Night 2 ] [ Designated as safety issue: Yes ]
    Mean PtcCO2 during night 2

  • Transcutaneous capnography (PtcCO2) [ Time Frame: Night 3 ] [ Designated as safety issue: Yes ]
    Mean PtcCO2 during night 3

  • Correlation between microarousal index and autonomic arousal index [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)
Estimated Enrollment: 10
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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
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
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130090

Locations
Switzerland
Geneva University hospital - Sleep laboratory
Geneva, Switzerland, 1211
Sponsors and Collaborators
Ligue Pulmonaire Genevoise
Investigators
Study Director: Jean-Paul Janssens, MD Geneva University Hospital
  More Information

No publications provided by Ligue Pulmonaire Genevoise

Additional 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
Study First Received: May 3, 2010
Last Updated: February 23, 2011
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on February 27, 2015