NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study

Acute Respiratory Failure Clinical Trial

— NINAVAPed  

Official title:

Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01873261
• Other study ID #: HULP-PI-3750
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2013
• Last updated: June 7, 2013
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: Hospital Universitario La Paz
• Contact: Pedro De la Oliva, MD, PhD
• Phone: +347277149
• Email: poliva.hulp[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational

Clinical Trial Summary

This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.

Description:

This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.

Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.

Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.

There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Age: > 1 month age to 18 years

• Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).

• Non intubated

• Admitted to the PICU

• Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)

Exclusion Criteria:

1. Patients younger than 1 month or older than 18 year

2. Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion

3. Facial trauma/burns

4. Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding

5. Fixed obstruction of the upper airway

6. Inability to protect airway

7. Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen.

8. Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min

9. Impaired consciousness defined as Glasgow coma scale < 10.

10. Bowel obstruction.

11. Untreated pneumothorax.

12. Poor short term prognosis (high risk of death in the next 3 months)

13. Known esophageal problem (hiatal hernia, esophageal varicosities)

14. Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.

15. Neuromuscular disease

16. Vomiting

17. Cough or gag reflex impairment.

18. Cyanotic congenital heart disease.

19. Complete absence of cooperation

20. This patient has been included (randomized) previously in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

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 (11)

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. — View Citation

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. — View Citation

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. Review. — 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

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

Muñoz-Bonet JI, Flor-Macián EM, Brines J, Roselló-Millet PM, Cruz Llopis M, López-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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Avoiding endotracheal intubation using non-invasive ventilation	The primary endpoint of this study is avoiding endotracheal intubation (ETI) (and conventional mechanical ventilation (MV)) using non-invasive ventilation (NIV). It is defined as no need for ETI (and MV) for at least 48h after the withdrawal of NIV.	During non invasive ventilation, an average of 2-3 days.	Yes
Secondary	Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV		During mechanical ventilation after NIV	Yes
Secondary	Length (days) of PICU stay after NIV	The patients will be follow up after NIV during the PICU stay, and average of two weeks	After NIV	Yes
Secondary	Length (days) hospital stay after NIV	The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.	After NIV	Yes