AzTrials
AzTrials

ObesityNCT01130090

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

A study testing Adjustment of back-up respiratory rate on bi-level ventilator in people with Obesity and Non Invasive Ventilation, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Non Invasive Ventilation
What is being tested?
Adjustment of back-up respiratory rate on bi-level ventilator
Type of treatment
Medical device
How many people
10 participants
Where
1 siteSwitzerland
Study dates
Sep 2008to Nov 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Geneva University hospital - Sleep laboratory

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: 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.
Read the 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.

Being tested
Adjustment of back-up respiratory rate on bi-level ventilator
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep structure

    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

    Measured: Night 1

  2. Sleep structure

    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

    Measured: Night 2

  3. Sleep structure

    Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals)

    Measured: Night 3

Secondary outcomes (6)

  1. Transcutaneous capnography (PtcCO2)

    Mean PtcCO2 during Night 1

    Measured: Night 1

  2. Transcutaneous capnography (PtcCO2)

    Mean PtcCO2 during night 2

    Measured: Night 2

  3. Transcutaneous capnography (PtcCO2)

    Mean PtcCO2 during night 3

    Measured: Night 3

  4. 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)

    Measured: Night 1

  5. Correlation between microarousal index and autonomic arousal index

    Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)

    Measured: Night 2

  6. Correlation between microarousal index and autonomic arousal index

    Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography)

    Measured: Night 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2010 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130090
Sponsor's protocol ID
CER- 08-131
Status last verified
Feb 2011
First submitted
3 May 2010
Last updated
24 Feb 2011
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 25737571

  • 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.

    PubMed 22556317

Questions about this trial

What is this clinical trial studying?

A study testing Adjustment of back-up respiratory rate on bi-level ventilator in people with Obesity and Non Invasive Ventilation, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep structure (time frame: Night 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01130090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in