Clinical trial NCT01159106: The Use of Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support During Asynchrony in Children
Official title: The Use of NAVA vs. Pressure Support During Asynchrony in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient/Ventilator Asynchrony
Keywords: Positive Pressure Ventilation
Neurally Adjusted Ventilatory Assist
Patient/ventilator Asynchrony
Pediatric patient
Infant
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.

Detailed description: Asynchrony during assisted ventilation in children is common because of the presence of uncuffed artificial airways and their rapid ventilatory rate with small volumes compared to adults.As a result, the most common approach to ventilatory support in children is pressure ventilation, since pressure targeted ventilation allows gas delivery to vary based on patient demand. In addition, many manufacturers have incorporated adjuncts designed to improve synchrony in pressure targeted ventilation. Most of today's ICU ventilators incorporate rise time and control of the breath termination criteria in pressure ventilation by either altering inspiratory time directly or adjusting the inspiratory flow termination criteria in pressure support ventilation. In addition, careful adjustment of trigger sensitivity, and insuring driving pressure is appropriately set to avoid large tidal volumes improves synchrony in many patients. However, in spite of all of these potential adjustments many pediatric patients are still asynchronous.

A recently released new mode of ventilation, NAVA (neurally adjusted ventilatory assist) is designed to reduce the asynchrony that exists between the ventilator and the patient. With NAVA, gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube (NGT) with EMG electrodes that cross the diaphragm. This NGT also functions similar to any standard NGT. NAVA is used to control all aspects of assisted ventilatory support. A number of preliminary studies in neonates and pediatric patients have demonstrated that patient ventilator synchrony is improved with the application of NAVA. In general, tidal volumes delivered by the ventilator are decreased, respiratory rates increased and peak inspiratory pressures decreased. In these studies, triggering and cycling of the ventilator are controlled by the diaphragmatic EMG in more than 70 % of the time. If the EMG signal does not activate or terminate positive pressure backup flow/pressure/time signal, control gas delivery -as is customary in standard modes of ventilatory support- takes over.

We hypothesize that the use of NAVA will improve trigger and flow synchrony in children and insure that tidal volumes are normalized (6 to 8 ml/kg) in these patients.

Asynchrony will be studied in 12 mechanically ventilated pediatric patients in the Pediatric ICU at Hospital Universitario Materno-Infantil La Paz in Madrid, Spain.

The study protocol has 5 phases

* Phase 0: patient asynchrony documentation and 10 min recording
* Phase 1: NAVA catheter insertion and 10 min recording in basal ventilatory mode after 20 min stabilization
* Phase 2: Pressure support is optimized and 10 min recording after 20 min stabilization
* Phase 3: NAVA mode ventilation and 10 min recording after 20 min stabilization
* Phase 4: Pressure support ventilation and 10 min recording after 20 min stabilization

Eligibility criteria: Inclusion Criteria:

* Trigger asynchrony
* Breath initiation asynchrony
* Breath termination asynchrony
* Patient ventilated by Servo i (Maquet Critical Care AB,Solna,Sweden)
* Patients breathing spontaneously with no control breaths

Exclusion Criteria:

* Shock
* Agitation
* Asynchrony caused by pain
* Abundant tracheal secretions

Primary outcomes:
measure: Level of asynchrony
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Massachusetts General Hospital
name: Robert M Kacmarek, PhD RRT FCCM
role: STUDY_DIRECTOR
affiliation: Hospital Universitario La Paz
name: Pedro de la Oliva, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Dr. Negrin
name: Jesus Villar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Demet Suleymanci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck J, Tucci M, Emeriaud G, Lacroix J, Sinderby C. Prolonged neural expiratory time induced by mechanical ventilation in infants. Pediatr Res. 2004 May;55(5):747-54. doi: 10.1203/01.PDR.0000119368.21770.33. Epub 2004 Jan 22.
citation: Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b.
citation: Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
citation: de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.