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
  Purpose

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
Chronic Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Groupe de Recherche sur le Handicap Respiratoire:

Estimated Enrollment: 10
Study Start Date: October 2010
Study Completion Date: June 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255111

Locations
France
Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital
Rouen, France
Sponsors and Collaborators
Groupe de Recherche sur le Handicap Respiratoire
Investigators
Principal Investigator: Pr. Antoine CUVELIER, MD, PhD Groupe de Recherche sur le Handicap Ventilatoire
  More Information

No publications provided

Responsible Party: Pr. Antoine CUVELIER, GRHV - UPRES EA3830
ClinicalTrials.gov Identifier: NCT01255111     History of Changes
Other Study ID Numbers: 2010AC1
Study First Received: December 4, 2010
Last Updated: June 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014