Respiratory InsufficiencyNCT01403584

Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm

A study testing AutoVPAP with addition of AutoEPAP and AutoVPAP with EPAP manually selected in people with Respiratory Insufficiency and Sleep Disordered Breathing, run by ResMed at 1 site in Germany.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Respiratory Insufficiency, Sleep Disordered Breathing
What is being tested?: AutoVPAP with addition of AutoEPAP and AutoVPAP with EPAP manually selected
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteGermany
Study dates: Jul 2011to Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure.
Previously stabilised on bilevel noninvasive pressure support ventilation.
Both genders, age <75years.
Previously shown to have a requirement for an EEP above cm H2O in order to maintain upper airway patency, or those in whom such a raised EEP would be expected, e.g. obese patients.
Patients also known to have adequate airway patency at an EEP of 4 to 5 cm H2O will be included to ensure specificity of the algorithm.

Who cannot join

Acute critical illness (e.g. acute coronary syndrome, stroke)
Serious anatomical variations of nose, sinuses, pharynx or oesophagus.
Any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.)
Age >75 years
Pregnancy
Epilepsy

Show all 10Show fewer

Psychiatric disorders that could possibly influence the study
Any kind of addiction
Insufficient knowledge of the language
Noninvasive ventilation otherwise contraindicated

Trial locations and contacts

1 site in 1 country.

Germany1 site

Abteilung Pneumologie - Universitätsklinik, Ruhrlandklinik
Essen, 45239

Other trials in Germany

About this study

Official title: Adjustment of Non-invasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Ventilatory Failure Using Automated End-expiratory Pressure (AutoEEP) Algorithm

The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure. For this purpose, The investigators will study different groups of patients, including those with obstructive and restrictive ventilatory defect, and obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure therapy.

Read the detailed description

Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV).

Optimal settings of non-invasive ventilation are usually titrated manually and require time and expertise. The development of systems lead to automated analysis and development of algorithms to adjust ventilators. However, there is a paucity of optimal algorithms, particularly the problem of upper airway obstruction. Therefore, the central aim of this study is to develop the automated setting of an end-expiratory positive airway pressure (EPAP), because upper airway obstruction is relatively common in this group of patients. We hypothesise that an automated end-expiratory airway pressure (AutoEEP) adjusting algorithm could overcome these problems and further optimise and adjust ventilator settings. Using non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep, we will measure physiological outcome parameters and apply an AutoEEP algorithm, comparing it against usual care.

Conditions: Respiratory Insufficiency, Sleep Disordered Breathing
Being tested: AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
Keywords: Breathing pattern, Gas exchange, Sleep quality
Medical subject headings: Respiratory Insufficiency, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

What participants receive

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

AutoVPAP with addition of AutoEPAPDevice
Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
AutoVPAP with EPAP manually selectedDevice
Conventionally applied Expiratory Positive Airway Pressure (EPAP)

Study groups in NCT01403584
Study group	Role	What they receive
AutoVPAP with addition of AutoEPAP	Experimental	This arm will receive conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night. Receives: Device: AutoVPAP with addition of AutoEPAP; Device: AutoVPAP with EPAP manually selected
AutoVPAP without addition of AutoEPAP	Active comparator	This arm will receive conventionally applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night. Receives: Device: AutoVPAP with addition of AutoEPAP; Device: AutoVPAP with EPAP manually selected

What is being measured

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

Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)
The AHI is a count of the number of pauses during sleep a person experiences. The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night
Measured: On completion of each consecutive night of polysomnography.

Secondary outcomes (1)

Mean SpO2
During sleep, pulse oximetery is recorded through a sensor on the participants finger
Measured: On completion of each night of 2 consecutive nights polysomnography.

Timeline

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

Jul 2011Feb 2015

First posted27 Jul 2011 (estimated)
Study startJul 2011
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
More trials run by ResMedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01403584
Sponsor's protocol ID: 09-4225
Status last verified: Mar 2021
First submitted: 25 Jul 2011
Last updated: 26 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Battisti A, Tassaux D, Bassin D, Jolliet P. Automatic adjustment of noninvasive pressure support with a bilevel home ventilator in patients with acute respiratory failure: a feasibility study. Intensive Care Med. 2007 Apr;33(4):632-8. doi: 10.1007/s00134-007-0550-1. Epub 2007 Feb 24.
PubMed 17323049

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adjustment of Non-invasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Ventilatory Failure Using Automated End-expiratory Pressure (AutoEEP) Algorithm
ClinicalTrials.gov ID: NCT01403584
Acronym / sponsor ID: 09-4225
Conditions: Respiratory Insufficiency, Sleep Disordered Breathing
Keywords: Breathing pattern, Gas exchange, Sleep quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: ResMedIndustry (pharma, biotech, devices)
Collaborators: University Hospital, Essen
Study start: Jul 2011
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 27 Jul 2011 (estimated)
Results: Posted 26 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
AutoVPAP with addition of AutoEPAP	Experimental	Device: AutoVPAP with addition of AutoEPAP, Device: AutoVPAP with EPAP manually selectedThis arm will receive conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night.
AutoVPAP without addition of AutoEPAP	Active comparator	Device: AutoVPAP with addition of AutoEPAP, Device: AutoVPAP with EPAP manually selectedThis arm will receive conventionally applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure.
Previously stabilised on bilevel noninvasive pressure support ventilation.
Both genders, age <75years.
Previously shown to have a requirement for an EEP above cm H2O in order to maintain upper airway patency, or those in whom such a raised EEP would be expected, e.g. obese patients.
Patients also known to have adequate airway patency at an EEP of 4 to 5 cm H2O will be included to ensure specificity of the algorithm.

Key exclusion criteria (10 listed)

Acute critical illness (e.g. acute coronary syndrome, stroke)
Serious anatomical variations of nose, sinuses, pharynx or oesophagus.
Any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.)
Age >75 years
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AutoVPAP with addition of AutoEPAPImplementation of automated algorithm for adjustment of conventional device parameter (EPAP0.	Device	AutoVPAP with addition of AutoEPAP, AutoVPAP without addition of AutoEPAP
AutoVPAP with EPAP manually selectedConventionally applied Expiratory Positive Airway Pressure (EPAP)	Device	AutoVPAP with addition of AutoEPAP, AutoVPAP without addition of AutoEPAP

Primary outcome

Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)
Time frame: On completion of each consecutive night of polysomnography.
The AHI is a count of the number of pauses during sleep a person experiences. The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night

1 secondary outcome

Mean SpO2
Time frame: On completion of each night of 2 consecutive nights polysomnography.

Results and safety

Results posted to the registry on 26 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AutoVPAP With Addition of AutoEPAP	11	11
AutoVPAP With EPAP Manually Selected	10	10

Primary outcome: Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)

Time frame: On completion of each consecutive night of polysomnography.. Mean (Standard Deviation). Unit: Events per hour of sleep

Measure	Automatic Algorithm - AutoVPAP With Addition of AutoEPAP n = 21	Conventional Therapy - AutoVPAP With EPAP Manually Selected n = 21
Value	1.3 (2.3)	1.7 (2.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The intervention took place over 2 nights of polysomnography. No adverse events occurred for any patient on any night polysomnography.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Automatic Algorithm - AutoVPAP With Addition of AutoEPAP	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Conventional Therapy - AutoVPAP With EPAP Manually Selected	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): Exclusion of patients whose fundamental disorder was sleep-disordered breathing with an incidental diagnosis of COPD or of OHS and only moderate obesity, and without other supporting evidence, turned out not to be practicable for all cases.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17323049Battisti A, Tassaux D, Bassin D, Jolliet P. Automatic adjustment of noninvasive pressure support with a bilevel home ventilator in patients with acute respiratory failure: a feasibility study. Intensive Care Med. 2007 Apr;33(4):632-8. doi: 10.1007/s00134-007-0550-1. Epub 2007 Feb 24.
Individual participant dataSharing planned: No

Related trials for Respiratory Insufficiency

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helmut Teschler, Dr. med. principal investigator

Abteilung Pneumologie - Universitätsklinik, Essen, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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 26 Mar 2021. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI) (time frame: On completion of each consecutive night of polysomnography.). 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 NCT01403584, which also lists 1 linked publication.

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 26 Mar 2021.