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NCT01255111 Clinical Trial

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

Chronic Respiratory Failure Clinical Trial

— ROOMILA  

Official title:
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01255111
Other study ID # 2010AC1
Secondary ID
Status Completed
Phase N/A
First received December 4, 2010
Last updated June 22, 2011
Start date October 2010
Est. completion date June 2011

Study information
Verified date June 2011
Source Groupe de Recherche sur le Handicap Respiratoire
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
Groupe de Recherche sur le Handicap Respiratoire

Country where clinical trial is conducted

France, 

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