NCT01130090

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

2.2 years

First QC Date

May 3, 2010

Last Update Submit

February 23, 2011

Conditions

ObesityNon Invasive Ventilation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Transcutaneous capnography (PtcCO2)

    Night 1

  • Transcutaneous capnography (PtcCO2)

    Night 2

  • Transcutaneous capnography (PtcCO2)

    Night 3

  • Correlation between microarousal index and autonomic arousal index

    Night 1

  • Correlation between microarousal index and autonomic arousal index

    Night 2

  • +1 more secondary outcomes

Interventions

Adjustment of back-up respiratory rate on bi-level ventilatorDEVICE

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University hospital - Sleep laboratory

Geneva, 1211, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 25737571DERIVED

  • 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.

    PMID: 22556317DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Paul Janssens, MD

    University Hospital, Geneva

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 25, 2010

Study Start

September 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

CH(1)