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

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Failure

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Groupe de Recherche sur le Handicap Respiratoire
• Investigators: Principal Investigator: Pr. Antoine CUVELIER, MD, PhD, Groupe de Recherche sur le Handicap Ventilatoire

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 4, 2010
• First Submitted That Met QC Criteria: December 4, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Sleep; Noninvasive ventilation; Chronic respiratory failure; Sleep fragmentation; Patient-ventilator interactions
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2010AC1