Respiratory FailureNAVANINCT02163382
Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation
A study testing Neurovent Monitor XIII in people with Respiratory Failure, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Mechanical ventilation permits to support the work of breathing in case of respiratory failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these complications. Read more about this study
- Who is it for?
- Ages 3 days to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Neurovent Monitor XIII
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to May 2013
- 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 3 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children >3 days and <18 years old
- Hospitalized in the pediatric intensive care unit, and requiring non invasive ventilation (including any ventilatory modes, with one (CPAP) or two level of pressure assist) for more than 6 hours according to the prescription of the attending physician
Who cannot join
- Contraindications to NAVA use or to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical, nasopharyngeal or esophageal regions)
- Hemodynamic instability requiring dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, or dobutamine.
- Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 > 60%, or PaCO2>80 mmHg on blood gas in the last hour.
- Absence of parental or tutor consent.
- Patient for whom a limitation of life support treatments is discussed or decided
Trial locations and contacts
1 site in 1 country.
About this study
Mechanical ventilation permits to support the work of breathing in case of respiratory failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these complications. However, NIV is not always successful and half of children in respiratory failure finally require invasive ventilation. A major cause of NIV failure is the ventilator inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted ventilatory assist) improves the detection of patient efforts during mechanical ventilation. The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and therefore permits to unload the patient ventilatory efforts.
Read the detailed description
Nasogastric tube installation to monitor electrical activation of the diaphragm (EAdi):
A specific nasogastric tube equipped with an array of microelectrodes (Edi catheter, Maquet, Solna, Sweden) will be installed after inclusion. This tube has an external aspect and size (6F, 8F, or 12F depending on the patient size) similar to usual nasogastric tubes. The gastric tube installation is extremely frequent in pediatric ICU, and systematic in patients with ventilatory support, to empty the gastric gas and permit the feeding. The new tube will stay in place after the study and could be used as a classic tube. The catheter position in esophagus will be adjusted using a special window of the Servo i ventilator screen, which permits to confirm the correct positioning close to the diaphragm [Barwing 2009]. It has recently been confirmed that Edi catheter placement is not difficult and that the correct placement of the nasogastric tube is actually facilitated by the possibility of activity monitoring [Green 2011].
RIP jacket installation:
A special jacket adapted to the patient size will be installed to monitor the lung volume changes by impedance plethysmography (RIP). This sleeveless jacket is constituted of a large band of distensible cloth in which 2 metallic coils are coated to record the impedance changes created by the ventilation. The RIP coils will be connected to the RIP monitoring module, and no volume calibration will be done to avoid the manipulation of patient airway. RIP monitoring is completely non-invasive and no complications are expected [Emeriaud 2010][Emeriaud 2008].
Baseline measurements:
The Edi tube is connected to the Servo i to monitor EAdi, but the patient remains connected to its usual ventilator with unmodified ventilator settings. Airway pressure, respiratory volume and flow will be recorded simultaneously with EAdi during 30 minutes.
Ventilator change:
If a different ventilator was used prior to the study, the patient will be installed on a Servo i ventilator, initially with the same ventilatory settings.
Determination of NAVA parameters:
The positive end expiratory pressure (PEEP) will not be modified. The NAVA level - the proportionality factor that converts EAdi (microV) into pressure support (cmH2O) - will be set using a specific window which simulates the pressure that would be delivered in NAVA. The NAVA level will be initially adjusted to match the simulated pressure with the actual assist pressure. If the patient is on CPAP (i.e. no assist pressure), the NAVA level will be initially set to match an assist pressure of 5 cmH2O above PEEP. The maximal pressure alarm will be set at 30 cmH2O.
NAVA period:
The NAVA mode will be activated for one hour, under the continuous supervision by a physician involved in the study, and with a continuous monitoring of vital signs including cardiac and respiratory rate, SaO2, respiratory distress signs, patient agitation, and the normal function of the ventilator. The NAVA level will be adjusted if the patient breathing frequency is > 40/min (progressive increase of NAVA level) or < 12/min (decrease of NAVA level), or if the delivered pressure is low (<3 cmH2O) due to air leaks. Ventilatory pressure, flow and volumes and EAdi will be continuously recorded during the last 30 minutes.
Second period with conventional NIV settings:
The patient will be installed again with the ventilatory settings prescribed prior to the study, and the ventilatory data will be recorded again for 30 minutes.
During the entire study, "usual" modifications of settings (e.g. adaptation of assist level, FiO2, or PEEP) considered by the attending physician, the nurse, or a respiratory therapist, will be permitted and documented.
End of the study:
At the end of the study, if a clear clinical benefit of one mode or setting is observed during the study, the attending physician will be informed to permit the optimal adaptation of the ventilatory assist.
- Conditions
- Respiratory Failure
- Being tested
- Neurovent Monitor XIII
- Keywords
- Nava, Non Invasive Ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovent Monitor XIIIDevice
Also called Health Canada approval number: 186536
Nasogastric tiube installation to monitor EAdi
Neurovent Monitor XIIIDevice
RIP jacket installation
Neurovent Monitor XIIIDevice
Ventilator change (if a different ventilator was used prior to the study).
Neurovent Monitor XIIIDevice
Determination of NAVA parametersVentilator
Neurovent Monitor XIIIDevice
Second period with conventional NIV settings
| Study group | Role | What they receive |
|---|---|---|
| Neurovent Monitor XIII | Experimental | 1 hour Ventilation with NAVA Receives: Device: Neurovent Monitor XIII |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity
The analysis of respiratory recordings will be conducted on 15 minute period during which the patient is not agitated, at the end of the 3 ventilation periods: baseline period with conventional parameters, NAVA period, and 2nd period with conventional parameters. The mean EAdi will be calculated as the area under the curve of EAdi versus time
Measured: up to 28 days
Secondary outcomes (1)
Percentage of time spent in asynchrony
The inspiratory and expiratory times of the patient and of the ventilator will be identified cycle-by-cycle from the tracing of EAdi and airway pressure, respectively. The percentage of time spent in asynchrony (discordance between the patient and the ventilator actions) will be calculated [Beck 2004], as well as the delay to activate or inactivate the ventilatory support. The number of non-assisted breaths (increase in EAdi without pressure elevation) and of auto-triggered breaths (assist delivered in absence of EAdi activation) will also be counted [Thille 2006; Vignaux 2009].
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 posted13 Jun 2014 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Guillaume Emeriaud, St. Justine's Hospital
- Investigators
- Philippe A Jouvet, MD, PhD, Principal investigator, St. Justine's HospitalSylvain Morneau, Principal investigator, St. Justine's HospitalJennifer Beck, PhD, Principal investigator, Li Ka Shing Knowledge Institute. St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163382
- Sponsor's protocol ID
- CHUSJ-3388
- Acronym
- NAVANI
- Status last verified
- Nov 2015
- First submitted
- 9 Jun 2014
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ducharme-Crevier L, Beck J, Essouri S, Jouvet P, Emeriaud G. Neurally adjusted ventilatory assist (NAVA) allows patient-ventilator synchrony during pediatric noninvasive ventilation: a crossover physiological study. Crit Care. 2015 Feb 17;19(1):44. doi: 10.1186/s13054-015-0770-7.
PubMed 25886793
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation
- ClinicalTrials.gov ID
- NCT02163382
- Acronym / sponsor ID
- NAVANI / CHUSJ-3388
- Conditions
- Respiratory Failure
- Keywords
- Nava, Non Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Jun 2014 (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.
Mechanical ventilation permits to support the work of breathing in case of respiratory failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these complications. However, NIV is not always successful and half of children in respiratory failure finally require invasive ventilation. A major cause of NIV failure is the ventilator inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted ventilatory assist) improves the detection of patient efforts during mechanical ventilation. The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and therefore permits to unload the patient ventilatory efforts.
Detailed description
Nasogastric tube installation to monitor electrical activation of the diaphragm (EAdi):
A specific nasogastric tube equipped with an array of microelectrodes (Edi catheter, Maquet, Solna, Sweden) will be installed after inclusion. This tube has an external aspect and size (6F, 8F, or 12F depending on the patient size) similar to usual nasogastric tubes. The gastric tube installation is extremely frequent in pediatric ICU, and systematic in patients with ventilatory support, to empty the gastric gas and permit the feeding. The new tube will stay in place after the study and could be used as a classic tube. The catheter position in esophagus will be adjusted using a special window of the Servo i ventilator screen, which permits to confirm the correct positioning close to the diaphragm [Barwing 2009]. It has recently been confirmed that Edi catheter placement is not difficult and that the correct placement of the nasogastric tube is actually facilitated by the possibility of activity monitoring [Green 2011].
RIP jacket installation:
A special jacket adapted to the patient size will be installed to monitor the lung volume changes by impedance plethysmography (RIP). This sleeveless jacket is constituted of a large band of distensible cloth in which 2 metallic coils are coated to record the impedance changes created by the ventilation. The RIP coils will be connected to the RIP monitoring module, and no volume calibration will be done to avoid the manipulation of patient airway. RIP monitoring is completely non-invasive and no complications are expected [Emeriaud 2010][Emeriaud 2008].
Baseline measurements:
The Edi tube is connected to the Servo i to monitor EAdi, but the patient remains connected to its usual ventilator with unmodified ventilator settings. Airway pressure, respiratory volume and flow will be recorded simultaneously with EAdi during 30 minutes.
Ventilator change:
If a different ventilator was used prior to the study, the patient will be installed on a Servo i ventilator, initially with the same ventilatory settings.
Determination of NAVA parameters:
The positive end expiratory pressure (PEEP) will not be modified. The NAVA level - the proportionality factor that converts EAdi (microV) into pressure support (cmH2O) - will be set using a specific window which simulates the pressure that would be delivered in NAVA. The NAVA level will be initially adjusted to match the simulated pressure with the actual assist pressure. If the patient is on CPAP (i.e. no assist pressure), the NAVA level will be initially set to match an assist pressure of 5 cmH2O above PEEP. The maximal pressure alarm will be set at 30 cmH2O.
NAVA period:
The NAVA mode will be activated for one hour, under the continuous supervision by a physician involved in the study, and with a continuous monitoring of vital signs including cardiac and respiratory rate, SaO2, respiratory distress signs, patient agitation, and the normal function of the ventilator. The NAVA level will be adjusted if the patient breathing frequency is > 40/min (progressive increase of NAVA level) or < 12/min (decrease of NAVA level), or if the delivered pressure is low (<3 cmH2O) due to air leaks. Ventilatory pressure, flow and volumes and EAdi will be continuously recorded during the last 30 minutes.
Second period with conventional NIV settings:
The patient will be installed again with the ventilatory settings prescribed prior to the study, and the ventilatory data will be recorded again for 30 minutes.
During the entire study, "usual" modifications of settings (e.g. adaptation of assist level, FiO2, or PEEP) considered by the attending physician, the nurse, or a respiratory therapist, will be permitted and documented.
End of the study:
At the end of the study, if a clear clinical benefit of one mode or setting is observed during the study, the attending physician will be informed to permit the optimal adaptation of the ventilatory assist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurovent Monitor XIII | Experimental | Device: Neurovent Monitor XIII1 hour Ventilation with NAVA |
Who may qualify
- Ages
- 3 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children >3 days and <18 years old
- Hospitalized in the pediatric intensive care unit, and requiring non invasive ventilation (including any ventilatory modes, with one (CPAP) or two level of pressure assist) for more than 6 hours according to the prescription of the attending physician
Key exclusion criteria (5 listed)
- Contraindications to NAVA use or to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical, nasopharyngeal or esophageal regions)
- Hemodynamic instability requiring dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, or dobutamine.
- Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 > 60%, or PaCO2>80 mmHg on blood gas in the last hour.
- Absence of parental or tutor consent.
- Patient for whom a limitation of life support treatments is discussed or decided
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 |
|---|---|---|
| Neurovent Monitor XIIIAlso: Health Canada approval number: 186536Nasogastric tiube installation to monitor EAdi | Device | Neurovent Monitor XIII |
| Neurovent Monitor XIIIRIP jacket installation | Device | Neurovent Monitor XIII |
| Neurovent Monitor XIIIVentilator change (if a different ventilator was used prior to the study). | Device | Neurovent Monitor XIII |
| Neurovent Monitor XIIIDetermination of NAVA parametersVentilator | Device | Neurovent Monitor XIII |
| Neurovent Monitor XIIISecond period with conventional NIV settings | Device | Neurovent Monitor XIII |
Primary outcome
The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity
Time frame: up to 28 days
The analysis of respiratory recordings will be conducted on 15 minute period during which the patient is not agitated, at the end of the 3 ventilation periods: baseline period with conventional parameters, NAVA period, and 2nd period with conventional parameters. The mean EAdi will be calculated as the area under the curve of EAdi versus time
1 secondary outcome
Percentage of time spent in asynchrony
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 23 Nov 2015.
- Derived from this study: PubMed 25886793Ducharme-Crevier L, Beck J, Essouri S, Jouvet P, Emeriaud G. Neurally adjusted ventilatory assist (NAVA) allows patient-ventilator synchrony during pediatric noninvasive ventilation: a crossover physiological study. Crit Care. 2015 Feb 17;19(1):44. doi: 10.1186/s13054-015-0770-7.
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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, PhD principal investigator
St. Justine's Hospital
Sylvain Morneau principal investigator
St. Justine's Hospital
Jennifer Beck, PhD principal investigator
Li Ka Shing Knowledge Institute. St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurovent Monitor XIII 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 2 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 23 Nov 2015. 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?
The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity (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 NCT02163382, 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 23 Nov 2015.