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Completed

NCT Number: NCT01748656

Target Volume in Noninvasive Positive Pressure Ventilation

Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option

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Key information

Conditions

Obesity Hypoventilation Syndrome Apnea Dyssomnias Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Laboratory, Grenoble Univeristy Hospital

Grenoble, 38900, France

About this study

RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
  • 18 to 75 years old
  • In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).

Exclusion criteria

  • patient treated with additional long term Oxygen therapy
  • Patient previously treated by AVAPS mode or IVAPS mode

Treatment and study plan

IVAPS

Device

IVAPS mode (RESMED Stelar 150) during 1 night

AVAPS

Device

AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

Primary outcomes

  1. Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)

    Time frame: 1 night

    transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.

Secondary outcomes

  1. Mean transcutaneous CO2 pressure during REM Sleep

    Time frame: 1 Night

  2. Mean nocturnal SpO2

    Time frame: 1 night

  3. Awake arterial PaCO2 after 1 hour of NIPPV withdrawal

    Time frame: After 1 night

  4. Micro-arousals/hour of sleep

    Time frame: 1 night

  5. Sleep Quality assess by Visual analogic scale (100mm)

    Time frame: 1 night

  6. Respiratory residual events detected by NIPPV built-in softwares

    Time frame: 1 Night

Sponsors and collaborators

Lead sponsor

AGIR à Dom

Other

Collaborators

  • ResMed

Registry information

Official study title

Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial

Acronym: CIBLE

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 12, 2012
Registry last updated
Mar 14, 2014

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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