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Sponsored by: |
Tyco Healthcare Group |
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Information provided by: | Tyco Healthcare Group |
ClinicalTrials.gov Identifier: | NCT00603096 |
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
Condition | Intervention |
---|---|
Obesity-Hypoventilation Syndrome (OHS) |
Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS) |
Estimated Enrollment: | 45 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
patients will benefit from a complete polysomnography under NIV
|
Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
|
2: Active Comparator
settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas
|
Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
|
Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maud Boucherie, CRA | maud.boucherie@covidien.com |
France, Cedex 9 | |
Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble | Recruiting |
Grenoble, Cedex 9, France, 38043 | |
Contact: Jean-Louis Pepin, Pr JLPepin@chu-grenoble.fr | |
Contact: Jean-Christian Borel JCBorel@chu-grenoble.fr |
Principal Investigator: | Jean-Louis pepin, Pr | CHU Grenoble |
Responsible Party: | tyco Healthcare Group ( EMEA Clinical Affairs Director ) |
Study ID Numbers: | 38/2006/2, Ethics Comittee ref.06-TYCO-1 |
Study First Received: | January 15, 2008 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00603096 |
Health Authority: | France: Institutional Ethical Committee |
Obesity Sleep Apnea Syndromes Apnea Obesity Hypoventilation Syndrome Sleep Apnea, Obstructive Respiration Disorders Hypoventilation Dyssomnias Sleep Disorders |
Overweight Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms, Respiratory Nutrition Disorders Overnutrition |
Pathologic Processes Disease Syndrome Nervous System Diseases |