VentilationNCT01056939
Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
A study testing Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) in people with Ventilation, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not. Read more about this study
- Who is it for?
- Ages 1 minute to 16 years
- Conditions the study is for
- Ventilation
- What is being tested?
- Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2009to May 2012
- 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 1 minute to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes
Who cannot join
- Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.
The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.
Read the detailed description
Asynchrony means that the timing of support given by ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.
In our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.
- Conditions
- Ventilation
- Being tested
- Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden), Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)
- Keywords
- Ventilatory care, children, intensive care, NAVA, Children needing ventilatory care
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)Device
Treatment with neurally adjusted ventilatory assist
Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)Device
Treatment with PC or PRVC ventilation.
| Study group | Role | What they receive |
|---|---|---|
| NAVA | Active comparator | Children randomised in this arm will be treated with neurally adjusted ventilatory assist Receives: Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) |
| Control | Active comparator | Patients randomized to control group will be treated with pressure controlled ventilation (PC) when they are newborns and older children in this group will be treated with pressure regulated volume controlled (PRVC) ventilation. Receives: Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the duration of mechanical ventilation
Measured: 30minutes-3weeks
Secondary outcomes (1)
Amount of sedative medication needed
Measured: 30minutes-3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merja Ålander, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056939
- Sponsor's protocol ID
- EETTMK:118/2008
- Status last verified
- May 2012
- First submitted
- 19 Jan 2010
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01056939
- Acronym / sponsor ID
- EETTMK:118/2008
- Conditions
- Ventilation
- Keywords
- Ventilatory care, children, intensive care, NAVA, Children needing ventilatory care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jan 2010 (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.
The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.
The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.
Detailed description
Asynchrony means that the timing of support given by ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.
In our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA | Active comparator | Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)Children randomised in this arm will be treated with neurally adjusted ventilatory assist |
| Control | Active comparator | Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)Patients randomized to control group will be treated with pressure controlled ventilation (PC) when they are newborns and older children in this group will be treated with pressure regulated volume controlled (PRVC) ventilation. |
Who may qualify
- Ages
- 1 minute to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes
Key exclusion criteria (1 listed)
- Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.
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 |
|---|---|---|
| Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)Treatment with neurally adjusted ventilatory assist | Device | NAVA |
| Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)Treatment with PC or PRVC ventilation. | Device | Control |
Primary outcome
Primary outcome is the duration of mechanical ventilation
Time frame: 30minutes-3weeks
1 secondary outcome
Amount of sedative medication needed
Time frame: 30minutes-3weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) in people with Ventilation, run by University of Oulu at 1 site in Finland.
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 25 May 2012. 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 Finland. 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?
Primary outcome is the duration of mechanical ventilation (time frame: 30minutes-3weeks). 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 25 May 2012.