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

This study has been completed.
Sponsor:
Information provided by:
Groupe de Recherche sur le Handicap Respiratoire
ClinicalTrials.gov Identifier:
NCT01255111
First received: December 4, 2010
Last updated: June 22, 2011
Last verified: June 2011

December 4, 2010
June 22, 2011
October 2010
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Complete list of historical versions of study NCT01255111 on ClinicalTrials.gov Archive Site
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Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with chronic respiratory failure at stable state who are indicated to domiciliary noninvasive ventilation

Chronic Respiratory Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2011
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01255111
2010AC1
No
Pr. Antoine CUVELIER, GRHV - UPRES EA3830
Groupe de Recherche sur le Handicap Respiratoire
Not Provided
Principal Investigator: Pr. Antoine CUVELIER, MD, PhD Groupe de Recherche sur le Handicap Ventilatoire
Groupe de Recherche sur le Handicap Respiratoire
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP