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Acute Respiratory FailureNINAVAPedNCT01873261

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

An observational study of Acute Respiratory Failure, run by Hospital Universitario La Paz at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Acute Respiratory Failure
How many people
60 participants
Where
1 siteSpain
Study dates
Mar 2012to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • Vomiting
  • Cough or gag reflex impairment.
  • Cyanotic congenital heart disease.
  • Complete absence of cooperation
  • This patient has been included (randomized) previously in the study

Trial locations and contacts

1 site in 1 country.

Pedro De la Oliva, MD, PhD contact

+347277149

poliva.hulp@salud.madrid.org

Spain1 site, 1 recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

    Pedro De la Oliva, MD,PhD, 0034917277149, poliva.hulp@salud.madrid.org

    Pedro De la Oliva, MD, PhD

    Recruiting

Other trials in Spain

About this study

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

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

Read the detailed 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.

Keywords
Neurally Adjusted Ventilatory Assist, Pediatric Acute Respiratory Failure, non-invasive ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

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

    Measured: During mechanical ventilation after NIV

  2. Length (days) of PICU stay after NIV

    The patients will be follow up after NIV during the PICU stay, and average of two weeks

    Measured: After NIV

  3. Length (days) hospital stay after NIV

    The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.

    Measured: After NIV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2013 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01873261
Sponsor's protocol ID
HULP-PI-3750
Acronym
NINAVAPed
Status last verified
Jun 2013
First submitted
19 Feb 2013
Last updated
10 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 12667269

  • 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.

    PubMed 17290566

  • 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.

    PubMed 14968216

  • 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.

    PubMed 9827833

  • 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.

    PubMed 16276332

  • 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.

    PubMed 20440111

  • 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.

    PubMed 15599160

  • 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.

    PubMed 18712350

  • 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.

    PubMed 19593246

  • 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.

    PubMed 20828233

  • 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.

    PubMed 20308933

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Failure, run by Hospital Universitario La Paz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pedro De la Oliva, MD, PhD (+347277149, poliva.hulp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Avoiding endotracheal intubation using non-invasive ventilation (time frame: During non invasive ventilation, an average of 2-3 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01873261, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.

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