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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130090
• Other study ID #: CER- 08-131
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: February 23, 2011
• Start date: September 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Ligue Pulmonaire Genevoise
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Non Invasive Ventilation
• Obesity

Intervention

Device:
• Adjustment of back-up respiratory rate on bi-level ventilator
3 consecutive nights in randomized order, in either "S" (Spontaneous) mode, "ST" (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in "ST" (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort

Locations

Country	Name	City	State
Switzerland	Geneva University hospital - Sleep laboratory	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ligue Pulmonaire Genevoise

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep structure	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)	Night 1	No
Primary	Sleep structure	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)	Night 2	No
Primary	Sleep structure	Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)	Night 3	No
Secondary	Transcutaneous capnography (PtcCO2)	Mean PtcCO2 during Night 1	Night 1	Yes
Secondary	Transcutaneous capnography (PtcCO2)	Mean PtcCO2 during night 2	Night 2	Yes
Secondary	Transcutaneous capnography (PtcCO2)	Mean PtcCO2 during night 3	Night 3	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No