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
  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

Resource links provided by NLM:


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
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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014