RespirationNCT00893087
Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care
A study testing Triggering mode of the ventilator and Triggering method of the ventilator in people with Respiration, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Respiration
- What is being tested?
- Triggering mode of the ventilator and Triggering method of the ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2009to Aug 2009
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children born over 30 weeks of gestation needing ventilatory care
Who cannot join
- Craniofacial malformation which does not allow feeding tobe positioning. Critical ventilatory or perfusion problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care
The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care.
Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.
Read the detailed description
Asynchrony means that the timing of support given by the 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 this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.
- Conditions
- Respiration
- Being tested
- Triggering mode of the ventilator, Triggering method of the ventilator
- Keywords
- Ventilatory care, children, intensive care, asynchrony, triggering, 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.
Triggering mode of the ventilatorDevice
10 min of each triggering mode
Triggering method of the ventilatorDevice
Flow triggering
Triggering method of the ventilatorDevice
Pressure triggering
Triggering method of the ventilatorDevice
NAVA triggering
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Flow triggering Receives: Device: Triggering mode of the ventilator; Device: Triggering method of the ventilator |
| 2 | Active comparator | Pressure triggering Receives: Device: Triggering mode of the ventilator; Device: Triggering method of the ventilator |
| 3 | Active comparator | NAVA triggering Receives: Device: Triggering mode of the ventilator; Device: Triggering method of the ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time in ventilator-patient synchrony in each of the assist modes.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespirationStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893087
- Sponsor's protocol ID
- EETTMK:122/2008
- Status last verified
- Jan 2010
- First submitted
- 3 May 2009
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care
- ClinicalTrials.gov ID
- NCT00893087
- Acronym / sponsor ID
- EETTMK:122/2008
- Conditions
- Respiration
- Keywords
- Ventilatory care, children, intensive care, asynchrony, triggering, Children needing ventilatory care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 May 2009 (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 study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care.
Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.
Detailed description
Asynchrony means that the timing of support given by the 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 this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Triggering mode of the ventilator, Device: Triggering method of the ventilatorFlow triggering |
| 2 | Active comparator | Device: Triggering mode of the ventilator, Device: Triggering method of the ventilatorPressure triggering |
| 3 | Active comparator | Device: Triggering mode of the ventilator, Device: Triggering method of the ventilatorNAVA triggering |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children born over 30 weeks of gestation needing ventilatory care
Key exclusion criteria (1 listed)
- Craniofacial malformation which does not allow feeding tobe 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 |
|---|---|---|
| Triggering mode of the ventilator10 min of each triggering mode | Device | 1, 2, 3 |
| Triggering method of the ventilatorFlow triggering | Device | 1 |
| Triggering method of the ventilatorPressure triggering | Device | 2 |
| Triggering method of the ventilatorNAVA triggering | Device | 3 |
Primary outcome
The time in ventilator-patient synchrony in each of the assist modes.
Time frame: 30 min
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 20 Jan 2010.
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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 Triggering mode of the ventilator and Triggering method of the ventilator in people with Respiration, 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 20 Jan 2010. 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?
The time in ventilator-patient synchrony in each of the assist modes. (time frame: 30 min). 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 20 Jan 2010.