The Use of Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support During Asynchrony in Children

Patient/Ventilator Asynchrony Clinical Trial

— NAVAChildren  

Official title:

The Use of NAVA vs. Pressure Support During Asynchrony in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01159106
• Other study ID #: HULP-PI-3132
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2010
• Last updated: July 8, 2010
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2010
• Source: Hospital Universitario La Paz
• Contact: Pedro De La Oliva, MD, PhD
• Email: poliva.hulp[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Patient/Ventilator Asynchrony

Intervention

Other:
• Pressure Support Ventilation
Spontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value
• Neurally adjusted ventilatory assist (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 with EMG electrodes that cross the diaphragm.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Epub 2004 Jan 22. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of asynchrony	Number of each defined forms of asynchrony per minute during pressure support and during NAVA Six forms of asynchrony will be identified during optimal pressure support and optimal NAVA: trigger asynchrony, breath initiation asynchrony and breath termination asynchrony, demand asynchrony, inspiratory asynchrony and neuro-asynchrony	3 hours	Yes