Impact of Non-intentional Leaks on Noninvasive Ventilation (NIV-Leaks)

This study has been completed.
Sponsor:
Information provided by:
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT00983411
First received: September 23, 2009
Last updated: May 19, 2011
Last verified: September 2009
  Purpose

The investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.

The main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (OHS) patients.

Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a random order with an automatically opening valve. Breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects will be recorded only during awakened state. OHS patients will be recorded both during awake and sleep sates.

Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing according to the different levels of leaks.


Condition Intervention
Intermittent Positive-pressure Ventilation
Respiratory Physiological Phenomena
Other: Non intentional leaks during non invasive ventilation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of Non-intentional Leaks on Breathing Pattern and Work of Breathing During Non-invasive Ventilation: Study in Awakened Healthy Subjects and Awakened Obesity Hypoventilation Syndrome(OHS)Patients and During the Sleep in OHS Patients.

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilation [ Time Frame: Oesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measure: Assessments of the pulse transit time (PTT) and measurement of the oral opening (JAWSENS-NOMICS)according to the levels of non intentional leaks during non invasive ventilation [ Time Frame: PTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy and OHS subjects
10 healthy subjects: 20 to 60 years old 10 patients with Obesity hypoventilation syndrome: 20 to 70 years old treated with nocturnal non invasive ventilation for at least three months.
Other: Non intentional leaks during non invasive ventilation
During NIV sessions (in awake state for both the 10 healthy and the 10 OHS subjects and during sleep only for the OHS subjects), the investigators will create several levels of non intentional leaks in a random order

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

10 healthy subjects recruited in professionnal area 10 patients with Obesity hypoventilation syndrome addressed to the sleep laboratory for clinical assessment

Criteria

Inclusion Criteria:

  • OHS patients, in stable stade, teated with nocturnal non invasive ventilation for at least three months.
  • Healthy subjects without known pathology

Exclusion Criteria:

  • OHS patients: instable cardio-respiratory status and/or acute cardio-respiratory failure three month before the inclusion. Latex allergy, oesophageal varices.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983411

Locations
France
Laboratoire EFCR et Sommeil CHU Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
AGIR à Dom
Investigators
Principal Investigator: Jean Louis Pepin, Pr Laboratoire EFCR et Sommeil, CHU Grenoble
  More Information

No publications provided by AGIR à Dom

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Jean Louis PEPIN, Laboratoire EFCR, Hopital Universitaire de Grenoble, France
ClinicalTrials.gov Identifier: NCT00983411     History of Changes
Other Study ID Numbers: AGIR-02
Study First Received: September 23, 2009
Last Updated: May 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AGIR à Dom:
non-invasive intermittent positive-pressure ventilation
work of breathing
Pulse transit time

Additional relevant MeSH terms:
Obesity Hypoventilation Syndrome
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Hypoventilation
Respiratory Insufficiency
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 22, 2014