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

NCT ID: NCT01159106

Last Updated: 2010-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-07-31

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

Conditions

Patient/Ventilator Asynchrony

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Pressure Support Ventilation

Spontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Hospital Universitario La Paz

Principal Investigators

Robert M Kacmarek, PhD RRT FCCM

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Pedro de la Oliva, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Jesus Villar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Dr. Negrin

Demet Suleymanci, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Hospital Universitario La Paz

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Pedro De La Oliva, MD, PhD

Role: CONTACT

poliva.hulp@salud.madrid.org

Facility Contacts

Pedro de la Oliva, MD PhD

Role: primary

poliva.hulp@salud.madrid.org

+347277149

References

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.

Reference Type: BACKGROUND

PMID: 14739354 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20083921 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19593246 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22481227 (View on PubMed)

Other Identifiers

HULP-PI-3132

Identifier Type: -

Identifier Source: org_study_id