Infant, PretermPhase 2NCT01389882
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
A Phase 2 study testing neurally adjusted ventilatory assist (NAVA) ventilator mode in people with Infant, Preterm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation… Read more about this study
- Who is it for?
- Ages Up to 12 weeks
- Conditions the study is for
- Infant, Preterm
- What is being tested?
- neurally adjusted ventilatory assist (NAVA) ventilator mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Aug 2011
- Phase
- Phase 2
- 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 Up to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants mechanically ventilated
- ventilatory set frequency is under 25
- with informed consent of their parents
Who cannot join
- major congenital anomalies
- patients without self respiratory effort
- use of sedative or anesthetic drugs
- grade III or IV intraventricular hemorrhage
- phrenic nerve palsy or insufficiency
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-733
About this study
Official title: Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
Read the detailed description
The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.
Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.
- Conditions
- Infant, Preterm
- Being tested
- neurally adjusted ventilatory assist (NAVA) ventilator mode
- Keywords
- mechanical ventilation, diaphragm electrical activity, pressure support
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurally adjusted ventilatory assist (NAVA) ventilator modeProcedure or surgery
Also called Servo-i (Maquet Critical Care AB, Solna, Sweden)
Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable.
| Study group | Role | What they receive |
|---|---|---|
| ventilator assist | Experimental | Not described Receives: Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Inspiratory Pressure
peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Secondary outcomes (11)
Mean Airway Pressure
mean airway pressure measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Minute Ventilation
Minute ventilation measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Expiratory Tidal Volume
Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Dynamic Compliance
Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Work of Breathing
Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Peak EAdi
Peak electrical activity of the diaphragm
Measured: four hours
Fraction of Oxygen
Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode
Measured: four hours
Capillary Blood pH
Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode
Measured: four hours
Capillary Blood pCO2
Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode
Measured: four hours
Capillary Blood pO2
Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode
Measured: four hours
Capillary Blood HCO3
Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode
Measured: four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
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.
- Other trials for Infant, PretermStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
- Investigators
- Han Suk Kim, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389882
- Sponsor's protocol ID
- VENT-01-NAVA
- Status last verified
- Jan 2012
- First submitted
- 1 Jul 2011
- Last updated
- 9 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)
- ClinicalTrials.gov ID
- NCT01389882
- Acronym / sponsor ID
- VENT-01-NAVA
- Conditions
- Infant, Preterm
- Keywords
- mechanical ventilation, diaphragm electrical activity, pressure support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 28 Oct 2011
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 test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
Detailed description
The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.
Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilator assist | Experimental | Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode |
Who may qualify
- Ages
- Up to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm infants mechanically ventilated
- ventilatory set frequency is under 25
- with informed consent of their parents
Key exclusion criteria (5 listed)
- major congenital anomalies
- patients without self respiratory effort
- use of sedative or anesthetic drugs
- grade III or IV intraventricular hemorrhage
- phrenic nerve palsy or insufficiency
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 (NAVA) ventilator modeAlso: Servo-i (Maquet Critical Care AB, Solna, Sweden)Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable. | Procedure or surgery | ventilator assist |
Primary outcome
Peak Inspiratory Pressure
Time frame: four hours
peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode
11 secondary outcomes
Mean Airway Pressure
Time frame: four hours
Minute Ventilation
Time frame: four hours
Expiratory Tidal Volume
Time frame: four hours
Dynamic Compliance
Time frame: four hours
Work of Breathing
Time frame: four hours
Peak EAdi
Time frame: four hours
Fraction of Oxygen
Time frame: four hours
Capillary Blood pH
Time frame: four hours
Capillary Blood pCO2
Time frame: four hours
Capillary Blood pO2
Time frame: four hours
Capillary Blood HCO3
Time frame: four hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Han Suk Kim, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neurally adjusted ventilatory assist (NAVA) ventilator mode in people with Infant, Preterm, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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 9 Jan 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2011). 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?
Peak Inspiratory Pressure (time frame: four hours). 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 9 Jan 2012.