Acute Respiratory FailureNCT01870089
SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study
A study testing SmartCare/PS-NIV Drägerwerk Lübeck Germany in people with Acute Respiratory Failure, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- SmartCare/PS-NIV Drägerwerk Lübeck Germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute respiratory failure requiring non invasive ventilation
- ICU patient equipped with an arterial line.
Who cannot join
- Contra-indications to NIV:
- impaired consciousness
- absence of patient cooperation
- severe hemodynamic instability
- vomiting
- facial lesions
Show all 9Show fewer
- indication for immediate intubation
- Acute neurological problem
- Poor short term prognosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Adult Intensive Care and Burn unit, University Hospital of Lausanne
Lausanne, 1011
About this study
Official title: Clinical Evaluation of an Automated Knowledge-based Computer Driven System (SmartCare/PS-NIV) Designed to Automatically Adapt Pressure Support Level and Expiratory Cycling During Non Invasive Ventilation, a Feasability Study.
Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians.
Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality.
Read more
NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment.
A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction.
The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.
- Conditions
- Acute Respiratory Failure
- Being tested
- SmartCare/PS-NIV Drägerwerk Lübeck Germany
- Keywords
- Non invasive ventilation, Computer-driven system, Acute respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartCare/PS-NIV Drägerwerk Lübeck GermanyDevice
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
The main aim of the study is to explore the feasibility of using the Smartcare-NIV system to deliver non-invasive ventilation (NIV) in case of acute respiratory failure. Practically, we will describe how the NIV tratment will go on when using the Smartcare system and report how the system automatically adapt the ventilator settings.
Measured: 45 minute NIV-treatment
Secondary outcomes (13)
Respiratory rate
Measured: 45 minutes
Minute ventilation
Measured: 45 minutes
Tidal volumes
Measured: 45 minutes
Leaks
Measured: 45 minutes
O2 saturation
Transcutaneous measurement
Measured: 45 minutes
Alarms generated by the ventilator
Measured: 45 minutes
Manual ventilator settings modifications required
Measured: 45 minutes
Patient-ventilator asynchronies
Measured: 45 minutes
Blood gas analysis
Two blood gas analysis will be done, one at the beginning and one at the end of the 45-minyte NIV treatment.
Measured: 45 minutes
Patient comfort
Patient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10.
Measured: 45 minutes
Percentage of time spent in a predifined comfort zone.
The comfort zone will be defined as respiratory rate between 14 and 29 breaths/minunte and tidal volume between 5 and 10 ml/ kg IBW
Measured: 45 minutes
Heart rate
Measured: 45 minutes
Blood pressure
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Enough data to conclude
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Philippe Jolliet, University of Lausanne Hospitals
- Investigators
- Philippe Jolliet, Prof, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870089
- Sponsor's protocol ID
- SmartCare/PS-NIV
- Status last verified
- May 2017
- First submitted
- 23 May 2013
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Automated Knowledge-based Computer Driven System (SmartCare/PS-NIV) Designed to Automatically Adapt Pressure Support Level and Expiratory Cycling During Non Invasive Ventilation, a Feasability Study.
- ClinicalTrials.gov ID
- NCT01870089
- Acronym / sponsor ID
- SmartCare/PS-NIV
- Conditions
- Acute Respiratory Failure
- Keywords
- Non invasive ventilation, Computer-driven system, Acute respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enough data to conclude
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians.
Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality.
NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment.
A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction.
The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute respiratory failure requiring non invasive ventilation
- ICU patient equipped with an arterial line.
Key exclusion criteria (9 listed)
- Contra-indications to NIV:
- impaired consciousness
- absence of patient cooperation
- severe hemodynamic instability
- vomiting
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 |
|---|---|---|
| SmartCare/PS-NIV Drägerwerk Lübeck Germany | Device | Study group |
Primary outcome
Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
Time frame: 45 minute NIV-treatment
The main aim of the study is to explore the feasibility of using the Smartcare-NIV system to deliver non-invasive ventilation (NIV) in case of acute respiratory failure. Practically, we will describe how the NIV tratment will go on when using the Smartcare system and report how the system automatically adapt the ventilator settings.
13 secondary outcomes
Respiratory rate
Time frame: 45 minutes
Minute ventilation
Time frame: 45 minutes
Tidal volumes
Time frame: 45 minutes
Leaks
Time frame: 45 minutes
O2 saturation
Time frame: 45 minutes
Alarms generated by the ventilator
Time frame: 45 minutes
Manual ventilator settings modifications required
Time frame: 45 minutes
Patient-ventilator asynchronies
Time frame: 45 minutes
Blood gas analysis
Time frame: 45 minutes
Patient comfort
Time frame: 45 minutes
Percentage of time spent in a predifined comfort zone.
Time frame: 45 minutes
Heart rate
Time frame: 45 minutes
Blood pressure
Time frame: 45 minutes
Results and safety
The study was stopped early (reason given: Enough data to conclude). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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.
Philippe Jolliet, Prof principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartCare/PS-NIV Drägerwerk Lübeck Germany in people with Acute Respiratory Failure, run by University of Lausanne Hospitals 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 8 May 2017. 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 was stopped early (reason given: Enough data to conclude). Results are not available in the source record.
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?
Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure. (time frame: 45 minute NIV-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2017.