- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163382
Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation (NAVANI)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T 1C5
- Guillaume Emeriaud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurovent Monitor XIII
1 hour Ventilation with NAVA
|
Nasogastric tiube installation to monitor EAdi
Other Names:
RIP jacket installation
Ventilator change (if a different ventilator was used prior to the study).
Determination of NAVA parametersVentilator
Second period with conventional NIV settings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of time spent in asynchrony
Time Frame: Up to 28 days
|
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].
|
Up to 28 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ability to obtain a correct EAdi signal
Time Frame: Up to 28 days
|
Up to 28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Beck, PhD, Li Ka Shing Knowledge Institute. St. Michael's Hospital
- Principal Investigator: Philippe A Jouvet, MD, PhD, St. Justine's Hospital
- Principal Investigator: Sylvain Morneau, St. Justine's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUSJ-3388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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