Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization (NIV-OHS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Tyco Healthcare Group.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Tyco Healthcare Group
Information provided by:
Tyco Healthcare Group
ClinicalTrials.gov Identifier:
NCT00603096
First received: January 15, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS) |
Resource links provided by NLM:
Further study details as provided by Tyco Healthcare Group:
Primary Outcome Measures:
- Diurnal PaCO2 [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
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.
|
|
Active Comparator: 2
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient male or female, aged 20 to 75 years
- Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
- Patient affiliated to a social security insurance
- Having given its written informed consent to participate to the study
Exclusion Criteria:
- Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
- Patients suffering from heart failure with periodic breathing
- Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
- Unbalanced Psychiatric Diseases
- Patients with a respiratory decompensation the month preceding the study
- Patients not autonomous in the use of the NIV
- Pacemaker patients, constituting a contraindication to magnetic stimulation
- Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
- Patients with long term by steroids or other anti-inflammatory drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603096
Contacts
| Contact: Maud Boucherie, CRA | maud.boucherie@covidien.com |
Locations
| France | |
| 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 | |
Sponsors and Collaborators
Tyco Healthcare Group
Investigators
| Principal Investigator: | Jean-Louis pepin, Pr | CHU Grenoble |
More Information
No publications provided by Tyco Healthcare Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | EMEA Clinical Affairs Director, tyco Healthcare Group |
| ClinicalTrials.gov Identifier: | NCT00603096 History of Changes |
| Other Study ID Numbers: | 38/2006/2, Ethics Comittee ref.06-TYCO-1 |
| Study First Received: | January 15, 2008 |
| Last Updated: | January 15, 2008 |
| Health Authority: | France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Obesity Obesity Hypoventilation Syndrome Hypoventilation Respiratory Insufficiency Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Sleep Apnea, Obstructive |
Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Signs and Symptoms, Respiratory |
ClinicalTrials.gov processed this record on May 19, 2013