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Completed

NCT Number: NCT01255111

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

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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Key information

Conditions

Chronic Respiratory Failure Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Groupe de Recherche sur le Handicap Respiratoire

Other

Registry information

Official study title

Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure

Acronym: ROOMILA

Important dates

Study start
2010
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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