Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- patient-ventilator synchrony
Study Overview
Brief 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. 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
patient-ventilator synchrony
Time Frame: up to 28 days
Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))
Secondary Outcomes
- Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi(up to 28 days)
- Tolerance(up to 28 days)
- Number of times back-up rate started (per hour) in NAVA mode(up to 28 days)
- Number of PEEP or NAVA level adjustments in NAVA mode(up to 28 days)
Investigators
Philippe Jouvet
Associate Professor
St. Justine's Hospital