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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01130090
Other study ID # CER- 08-131
Secondary ID
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


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
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