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Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA) (ROOMILA)

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ClinicalTrials.gov Identifier: NCT01255111
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Groupe de Recherche sur le Handicap Respiratoire

Study Description
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Brief Summary:

BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure.

AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory.

PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep.

EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.


Condition or disease
Chronic Respiratory Failure

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure
Study Start Date : October 2010
Actual Study Completion Date : June 2011

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic respiratory failure at stable state who are indicated to domiciliary noninvasive ventilation
Criteria

Inclusion Criteria:

  • Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines.

Exclusion Criteria:

  • Decompensated respiratory failure attested by a pH <7.35,
  • Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection,
  • Respiratory frequency >30/min.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255111


Locations
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France
Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital
Rouen, France
Sponsors and Collaborators
Groupe de Recherche sur le Handicap Respiratoire
Investigators
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Principal Investigator: Pr. Antoine CUVELIER, MD, PhD Groupe de Recherche sur le Handicap Ventilatoire
More Information
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Responsible Party: Pr. Antoine CUVELIER, GRHV - UPRES EA3830
ClinicalTrials.gov Identifier: NCT01255111    
Other Study ID Numbers: 2010AC1
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by Groupe de Recherche sur le Handicap Respiratoire:
Chronic respiratory failure
Noninvasive ventilation
Patient-ventilator interactions
Sleep
Sleep fragmentation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases