NCT01873261

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

February 19, 2013

Last Update Submit

June 7, 2013

Conditions

Acute Respiratory Failure

Keywords

Neurally Adjusted Ventilatory AssistPediatric Acute Respiratory Failurenon-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV

    During mechanical ventilation after NIV

  • Length (days) of PICU stay after NIV

    After NIV

  • Length (days) hospital stay after NIV

    After NIV

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children from 1 month to 18 years admitted to the PICU with moderate/severe acute respiratory failure minimally sedated/agitated

You may qualify if:

  • 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)

You may not qualify if:

  • Patients younger than 1 month or older than 18 year
  • 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.
  • Neuromuscular disease
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 12667269BACKGROUND

  • 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: 17290566BACKGROUND

  • 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: 14968216BACKGROUND

  • 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: 9827833BACKGROUND

  • 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: 16276332BACKGROUND

  • 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: 20440111BACKGROUND

  • 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: 15599160BACKGROUND

  • 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: 18712350BACKGROUND

  • 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: 19593246BACKGROUND

  • 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: 20828233BACKGROUND

  • 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: 20308933BACKGROUND

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

+347277149poliva.hulp@salud.madrid.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 19, 2013

First Posted

June 10, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

ES(1)