Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency

Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency

In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use

• Spontaneous mode (S)
• Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the respiratory rate of the patient
• Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue has to our knowledge only been marginally studied without any consensus.

Study Overview

• Status: Completed
• Conditions: Obesity; Non Invasive Ventilation
• Intervention / Treatment: Device: Adjustment of back-up respiratory rate on bi-level ventilator

Detailed Description

Eligibility: patients under home bi-level pressure support ventilation for obesity hypoventilation in a stable clinical condition, aged over 18

Methods:

Three consecutive sleep studies in a randomised sequence with usual parameters Inspiratory Positive Airway Pressure(IPAP), Expiratory Positive Airway Pressure (EPAP) and change of only back up respiratory rate (RR): one night in a spontaneous mode, one with an intermediate RR, and one with a RR above that of the patient

Endpoints:

Quality of sleep and sleep structure (polysomnography), patient-ventilator synchronisation and respiratory events under NIV, efficacy of ventilation: oxygen saturation measured by pulse oxymetry (SaO2); transcutaneous capnography (PtcCO2), and comfort.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Geneva University hospital - Sleep laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obesity-hypoventilation (OHS) patients, in stable clinical condition, treated with domiciliary nocturnal non invasive ventilation for at least two months

Exclusion Criteria:

• OHS patients: unstable cardio-respiratory status and/or acute cardio-respiratory failure three months before inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep structure	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)	Night 1
Sleep structure	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)	Night 2
Sleep structure	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)	Night 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcutaneous capnography (PtcCO2)	Mean PtcCO2 during Night 1	Night 1
Transcutaneous capnography (PtcCO2)	Mean PtcCO2 during night 2	Night 2
Transcutaneous capnography (PtcCO2)	Mean PtcCO2 during night 3	Night 3
Correlation between microarousal index and autonomic arousal index	Correlation between microarousal index (assessed by EEG) and autonomic arousal index under NIV (assessed by pulse plethysmography)	Night 1
Correlation between microarousal index and autonomic arousal index	Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)	Night 2
Correlation between microarousal index and autonomic arousal index	Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)	Night 3

Collaborators and Investigators

• Sponsor: Ligue Pulmonaire Genevoise
• Investigators: Study Director: Jean-Paul Janssens, MD, University Hospital, Geneva

Publications and helpful links

General Publications

• Georges M, Adler D, Contal O, Espa F, Perrig S, Pepin JL, Janssens JP. Reliability of Apnea-Hypopnea Index Measured by a Home Bi-Level Pressure Support Ventilator Versus a Polysomnographic Assessment. Respir Care. 2015 Jul;60(7):1051-6. doi: 10.4187/respcare.03633. Epub 2015 Mar 3.
• Contal O, Adler D, Borel JC, Espa F, Perrig S, Rodenstein D, Pepin JL, Janssens JP. Impact of different backup respiratory rates on the efficacy of noninvasive positive pressure ventilation in obesity hypoventilation syndrome: a randomized trial. Chest. 2013 Jan;143(1):37-46. doi: 10.1378/chest.11-2848.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 24, 2010
• First Posted (Estimate): May 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: CER- 08-131