Respiratory FailureNAVANCT00603174
Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory Failure
A study testing neurally adjusted ventilatory assist (NAVA) in people with Respiratory Failure, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- neurally adjusted ventilatory assist (NAVA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Sep 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Intubated and mechanically ventilated infant with respiratory failure < 1 year old)
- Breathing spontaneously, as defined by the ability to trigger the ventilator
- The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: pressure plateau < 22 cm H2O (above PEEP) and PEEP ≤ 6 cm H2O.
Who cannot join
- Pneumothorax
- Degenerative neuromuscular disease
- Bleeding disorders
- Cardiovascular instability defined by vasopressors infusion (dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, dobutamine, vasopressin)
- Cyanotic congenital cardiovascular disease
- Phrenic nerve damage/diaphragm paralysis
Show all 10Show fewer
- Esophageal perforation
- Use of high frequency oscillatory or jet ventilation
- Contraindication to changing naso gastric tube
- Infant is deemed "too unstable" by the attending physician
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Center -CHU Sainte Justine - University of Montreal
Montreal, Quebec, H3T 1C5
About this study
Official title: Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I
The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in infants by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating an infant on NAVA with the Servoi for 12 hours, and to compare it to conventional ventilation.
Read the detailed description
Research Design and Methods
Aim: To demonstrate the feasibility and efficacy of delivering NAVA in an intubated infant with the Servoi ventilator.
Measurements: All ventilatory and EAdi parameters will be stored in a laptop computer connected to the ventilator. SAO2 will be measured via pulse oximetry with a probe placed on one of the infant's extremities. End Tidal PCO2 measurements will also be made via probe placed on the Y piece of the respirator circuit.
General protocol sequence:
- All patients in the PICU at HSJ screened daily for eligibility
- Eligible cases reviewed with attending team and study team
- Informed consent obtained from parents or guardian
- Change to Servoi ventilator (conventional settings)
- Nasogastric tube replacement
- Monitor EAdi during conventional settings
- Adjust PEEP to minimize tonic activity
- NAVA level titration
- Application of NAVA for 12 hours with the titrated settings of PEEP and NAVA level.
- Return to conventional ventilator settings on servoi and monitor for 1 hour
NAVA for 12 hours Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.
The NAVA level and PEEP levels can be adjusted throughout the study period, and is based on clinical judgment (as they would routinely do for a conventional mode). Following any new setting, the 12 hour period will continue with those new settings. Following the end of this 12th hour of NAVA, the feeding tube with the sensors will remain in place for feeding the patient as per ICU protocol.
Protocol termination criteria: If the infant demonstrates a sustained change in any of the following, the protocol will be terminated:
- Sustained decrease in SaO2 < 92% requiring increase in FIO2 > 60%
- End tidal PCO2 > 60 mm Hg requiring progressive increases in the NAVA level,
- Sustained increase in heart rate>180 bpm during 15 min,
- Sustained increase in respiratory rate>60 bpm during 15 min,
- Uncontrolled agitation judged by the attending physician
Monitoring during conventional ventilation after discontinuation of NAVA (1 hour):
In order to compare NAVA to conventional ventilation, monitoring will be continued with conventional settings on the Servoi ventilator for 1 hour. The following will be monitored and recorded at 20 min intervals: Phasic EAdi, tonic EAdi, tidal volume, respiratory rate, saturation, CO2, HR. Following this, the baby will be returned to the ventilator and settings determined by the clinical team.
Primary outcomes:
- Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))
Secondary outcomes:
- Phasic EAdi
- Tonic EAdi
- tidal volume, airway pressure, respiratory rate
- SAO2, End Tidal PCO2, FIO2 Number of times back-up rate started (per hour)
- Number of PEEP or NAVA level adjustments
Analysis and statistics
NAVA level titration: A continuous analysis will be performed breath-by-breath for phasic EAdi, ventilator-delivered pressure, respiratory rate and tidal volume. These values will be plotted versus the NAVA level. The NAVA level at the inflection point will be compared to the NAVA level initially used to match the conventional ventilation settings.
NAVA for 12 hours: EAdi signals will be processed automatically by the ventilator with standardized automated algorithms that have been implemented in to the Servoi. Phasic and tonic EAdi, as well as the ventilatory parameters (Vt, rr, SAO2, CO2) will be quantified breath-by breath and the last 20 min of each hour will be analyzed.
IN order to compare patient-ventilator synchrony between NAVA vs Conventional ventilation, trigger delays and cycling-off delays will be compared for each subject between the 2 modes. Paired t-tests will be used for this comparison.
Repeated measures ANOVA will be used to verify significant changes in variables over the twelve hour intervention period. The impact of PEEP on tonic diaphragm activity and the impact of NAVA level on tidal volume, pressures, and phasic diaphragm activity will also be compared by RM ANOVA.
Sample size determination: This is a case study and we will include 5 infants.
- Conditions
- Respiratory Failure
- Being tested
- neurally adjusted ventilatory assist (NAVA)
- Keywords
- NAVA, mechanical ventilation, infants, pediatric intensive care, infant
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurally adjusted ventilatory assist (NAVA)Device
Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intubated and mechanically ventilated infants with respiratory failure (age < 1 year old). see inclusion-exclusion criteria. Receives: Device: neurally adjusted ventilatory assist (NAVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-ventilator synchrony
Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))
Measured: up to 28 days
Secondary outcomes (4)
Tolerance
Evolution of tidal volume, airway pressure, respiratory rate, SAO2, End Tidal PCO2, FIO2
Measured: up to 28 days
Number of times back-up rate started (per hour) in NAVA mode
Measured: up to 28 days
Number of PEEP or NAVA level adjustments in NAVA mode
Measured: up to 28 days
Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi
Phasic EAdi and tonic EAdi compared between pressure support, pressure control and NAVA modes
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Philippe Jouvet, St. Justine's Hospital
- Investigators
- Philippe A Jouvet, MD, Principal investigator, Université de MontréalJennifer Beck, PhD, Principal investigator, SunnyBrook Health Sciences Centre - Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603174
- Sponsor's protocol ID
- HSJ 2537
- Acronym
- NAVA
- Status last verified
- Sep 2012
- First submitted
- 21 Nov 2007
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinderby C, Beck J, Spahija J, de Marchie M, Lacroix J, Navalesi P, Slutsky AS. Inspiratory muscle unloading by neurally adjusted ventilatory assist during maximal inspiratory efforts in healthy subjects. Chest. 2007 Mar;131(3):711-717. doi: 10.1378/chest.06-1909.
PubMed 17356084
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I
- ClinicalTrials.gov ID
- NCT00603174
- Acronym / sponsor ID
- NAVA / HSJ 2537
- Conditions
- Respiratory Failure
- Keywords
- NAVA, mechanical ventilation, infants, pediatric intensive care, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Jan 2008 (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 present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in infants by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating an infant on NAVA with the Servoi for 12 hours, and to compare it to conventional ventilation.
Detailed description
Research Design and Methods
Aim: To demonstrate the feasibility and efficacy of delivering NAVA in an intubated infant with the Servoi ventilator.
Measurements: All ventilatory and EAdi parameters will be stored in a laptop computer connected to the ventilator. SAO2 will be measured via pulse oximetry with a probe placed on one of the infant's extremities. End Tidal PCO2 measurements will also be made via probe placed on the Y piece of the respirator circuit.
General protocol sequence:
- All patients in the PICU at HSJ screened daily for eligibility
- Eligible cases reviewed with attending team and study team
- Informed consent obtained from parents or guardian
- Change to Servoi ventilator (conventional settings)
- Nasogastric tube replacement
- Monitor EAdi during conventional settings
- Adjust PEEP to minimize tonic activity
- NAVA level titration
- Application of NAVA for 12 hours with the titrated settings of PEEP and NAVA level.
- Return to conventional ventilator settings on servoi and monitor for 1 hour
NAVA for 12 hours Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.
The NAVA level and PEEP levels can be adjusted throughout the study period, and is based on clinical judgment (as they would routinely do for a conventional mode). Following any new setting, the 12 hour period will continue with those new settings. Following the end of this 12th hour of NAVA, the feeding tube with the sensors will remain in place for feeding the patient as per ICU protocol.
Protocol termination criteria: If the infant demonstrates a sustained change in any of the following, the protocol will be terminated:
- Sustained decrease in SaO2 < 92% requiring increase in FIO2 > 60%
- End tidal PCO2 > 60 mm Hg requiring progressive increases in the NAVA level,
- Sustained increase in heart rate>180 bpm during 15 min,
- Sustained increase in respiratory rate>60 bpm during 15 min,
- Uncontrolled agitation judged by the attending physician
Monitoring during conventional ventilation after discontinuation of NAVA (1 hour):
In order to compare NAVA to conventional ventilation, monitoring will be continued with conventional settings on the Servoi ventilator for 1 hour. The following will be monitored and recorded at 20 min intervals: Phasic EAdi, tonic EAdi, tidal volume, respiratory rate, saturation, CO2, HR. Following this, the baby will be returned to the ventilator and settings determined by the clinical team.
Primary outcomes:
- Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))
Secondary outcomes:
- Phasic EAdi
- Tonic EAdi
- tidal volume, airway pressure, respiratory rate
- SAO2, End Tidal PCO2, FIO2 Number of times back-up rate started (per hour)
- Number of PEEP or NAVA level adjustments
Analysis and statistics
NAVA level titration: A continuous analysis will be performed breath-by-breath for phasic EAdi, ventilator-delivered pressure, respiratory rate and tidal volume. These values will be plotted versus the NAVA level. The NAVA level at the inflection point will be compared to the NAVA level initially used to match the conventional ventilation settings.
NAVA for 12 hours: EAdi signals will be processed automatically by the ventilator with standardized automated algorithms that have been implemented in to the Servoi. Phasic and tonic EAdi, as well as the ventilatory parameters (Vt, rr, SAO2, CO2) will be quantified breath-by breath and the last 20 min of each hour will be analyzed.
IN order to compare patient-ventilator synchrony between NAVA vs Conventional ventilation, trigger delays and cycling-off delays will be compared for each subject between the 2 modes. Paired t-tests will be used for this comparison.
Repeated measures ANOVA will be used to verify significant changes in variables over the twelve hour intervention period. The impact of PEEP on tonic diaphragm activity and the impact of NAVA level on tidal volume, pressures, and phasic diaphragm activity will also be compared by RM ANOVA.
Sample size determination: This is a case study and we will include 5 infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: neurally adjusted ventilatory assist (NAVA)Intubated and mechanically ventilated infants with respiratory failure (age < 1 year old). see inclusion-exclusion criteria. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Intubated and mechanically ventilated infant with respiratory failure < 1 year old)
- Breathing spontaneously, as defined by the ability to trigger the ventilator
- The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: pressure plateau < 22 cm H2O (above PEEP) and PEEP ≤ 6 cm H2O.
Key exclusion criteria (10 listed)
- Pneumothorax
- Degenerative neuromuscular disease
- Bleeding disorders
- Cardiovascular instability defined by vasopressors infusion (dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, dobutamine, vasopressin)
- Cyanotic congenital cardiovascular disease
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)Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate. | Device | A |
Primary outcome
patient-ventilator synchrony
Time frame: up to 28 days
Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))
4 secondary outcomes
Tolerance
Time frame: up to 28 days
Number of times back-up rate started (per hour) in NAVA mode
Time frame: up to 28 days
Number of PEEP or NAVA level adjustments in NAVA mode
Time frame: up to 28 days
Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi
Time frame: up to 28 days
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 19 Sep 2012.
- Background: PubMed 17356084Sinderby C, Beck J, Spahija J, de Marchie M, Lacroix J, Navalesi P, Slutsky AS. Inspiratory muscle unloading by neurally adjusted ventilatory assist during maximal inspiratory efforts in healthy subjects. Chest. 2007 Mar;131(3):711-717. doi: 10.1378/chest.06-1909.
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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 A Jouvet, MD principal investigator
Université de Montréal
Jennifer Beck, PhD principal investigator
SunnyBrook Health Sciences Centre - Toronto
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 (NAVA) in people with Respiratory Failure, run by St. Justine's Hospital at 1 site in Canada.
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 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 19 Sep 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 Canada. 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?
patient-ventilator synchrony (time frame: up to 28 days). 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 NCT00603174, 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 19 Sep 2012.