Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure

NCT01873521 | Unknown Phase 4 DMC

• 1 other identifier: HULP-PI-3751
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to pressure support to provide noninvasive ventilation to children will result in a decrease in the number of children with moderate to severe respiratory failure failing noninvasive ventilation and requiring endotracheal intubation. It is further hypothesized that noninvasive ventilation with NAVA compared to pressure support will result in a decrease in the length of mechanical ventilation, and the length of PICU and hospital stay.

Conditions

Pediatric Acute Respiratory Failure

Keywords

Positive Pressure Ventilation; Neurally Adjusted Ventilatory Assist; Patient/ventilator Asynchrony; Pediatric patient; Infant

Outcome Measures

Primary Outcomes (1)

• Avoiding endotracheal intubation

  The primary objective of this study is to demonstrate that the use of NAVA to provide noninvasive ventilatory support (NIV NAVA) compared to pressure support (NIV PS) in pediatric patients with moderate to severe respiratory failure decreases the noninvasive ventilation failure rate by decreasing the number of patients requiring endotracheal intubation (ETI).

  During non invasive ventilation, an average of 2-3 days.

Secondary Outcomes (2)

• Length (days) of PICU stay after NIV

  Length (days) of PICU stay after NIV, an average of 1 week.

• Length (days) hospital stay after NIV

  Length (days) hospital stay after NIV, an average of 1-2 weeks

Study Arms (2)

NIV PS

ACTIVE COMPARATOR

The patients in this arms will received non invasive ventilation in PS mode.

Procedure: Non invasive ventilation

NIV NAVA

ACTIVE COMPARATOR

The patients in this arm will received non invasive ventilation in NAVA mode.

Procedure: Non invasive ventilation

Interventions

Non invasive ventilation PROCEDURE

NIV NAVA; NIV PS

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \> 1 month age or weight \> 3 Kg to 18 years
• Not intubated.
• Admitted to the PICU.
• Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2).
• Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) defined as: a) Modified Silverman-Wood Downess test \>or= 5 or \<or= 9; b) Hypoxemic ARF(SpO2\< 94% FiO2 0,5). c)Hypercapnic ARF (PaCO2 (mmHg) and/or pH \<7,30)
• The attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).

You may not qualify if:

• Patients younger than 1 month or older than 18 year
• Severe ARF defined as Modified Silverman-Wood Downes test \>9.
• Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
• Facial trauma/burns
• Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
• Fixed obstruction of the upper airway.
• Inability to protect airway
• Life threatening hypoxemia defined as SpaO2 \<90% with FiO2 \> 0.8 on hi-flow oxygen.
• Hemodynamic instability: refractory at volume expansion \>60 ml/kg and dopamine \>10 mcg/kg/min
• Impaired consciousness defined as Glasgow coma scale \< 10.
• Bowel obstruction.
• Untreated pneumothorax.
• Poor short term prognosis (high risk of death in the next 3 months)
• Known esophageal problem (hiatal hernia, esophageal varicosities)
• Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (11)

• Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8.

  PMID: 12667269 BACKGROUND

• Al-Mutairi SS, Al-Deen JS. Non-invasive positive pressure ventilation in acute respiratory failure. An alternative modality to invasive ventilation at a general hospital. Saudi Med J. 2004 Feb;25(2):190-4.

  PMID: 14968216 BACKGROUND

• L'HerE, Moriconi M, Texier F, Bouquin V, Kaba L, Renault A, Garo B, Boles JM. Non-invasive continuous positive airway pressure in acute hypoxaemic respiratory failure--experience of an emergency department. Eur J Emerg Med. 1998 Sep;5(3):313-8.

  PMID: 9827833 BACKGROUND

• Bernet V, Hug MI, Frey B. Predictive factors for the success of noninvasive mask ventilation in infants and children with acute respiratory failure. Pediatr Crit Care Med. 2005 Nov;6(6):660-4. doi: 10.1097/01.pcc.0000170612.16938.f6.

  PMID: 16276332 BACKGROUND

• Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.

  PMID: 15599160 BACKGROUND

• Kendirli T, Kavaz A, Yalaki Z, Ozturk Hismi B, Derelli E, Ince E. Mechanical ventilation in children. Turk J Pediatr. 2006 Oct-Dec;48(4):323-7.

  PMID: 17290566 BACKGROUND

• Calderini E, Chidini G, Pelosi P. What are the current indications for noninvasive ventilation in children? Curr Opin Anaesthesiol. 2010 Jun;23(3):368-74. doi: 10.1097/ACO.0b013e328339507b.

  PMID: 20440111 BACKGROUND

• Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.

  PMID: 18712350 BACKGROUND

• 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.

  PMID: 19593246 BACKGROUND

• Biban P, Serra A, Polese G, Soffiati M, Santuz P. Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:38-40. doi: 10.3109/14767058.2010.510018.

  PMID: 20828233 BACKGROUND

• Munoz-Bonet JI, Flor-Macian EM, Brines J, Rosello-Millet PM, Cruz Llopis M, Lopez-Prats JL, Castillo S. Predictive factors for the outcome of noninvasive ventilation in pediatric acute respiratory failure. Pediatr Crit Care Med. 2010 Nov;11(6):675-80. doi: 10.1097/PCC.0b013e3181d8e303.

  PMID: 20308933 BACKGROUND

MeSH Terms

Conditions

Patient-Ventilator Asynchrony

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Robert M Kacmarek, PhD RRT FCCM

  Massachusetts General Hospital, Boston, USA

  STUDY DIRECTOR

• Jesús Villar, MD,PhD

  Hospital Universitario Dr. Negrin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro De la Oliva, MD, PhD

CONTACT

+34917277149; pedro.oliva@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2016
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

ES (1)