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Completed

NCT Number: NCT01130090

Patient-ventilator Interactions in Long Term Non-invasive Ventilation: 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.

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Key information

Conditions

Obesity Body Weight Non Invasive Ventilation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University hospital - Sleep laboratory

Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjustment of back-up respiratory rate on bi-level ventilator

Device

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ligue Pulmonaire Genevoise

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 25, 2010
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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