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Using Nasal Broadband Glasses in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU (HFNC)

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ClinicalTrials.gov Identifier: NCT02791711
Recruitment Status : Completed
First Posted : June 7, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Study Description
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Brief Summary:

The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.

Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. This device generates a continuous positive pressure in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma.


Condition or disease Intervention/treatment Phase
Bronchiolitis Other: High Flow Nasal Cannula Not Applicable

Detailed Description:

Bronchiolitis in infants is a common and potentially serious disease. It corresponds to an acute pulmonary disease and dyspnea usually viral (70 to 80% of Respiratory syncytial virus RSV in infants less than 1 year). It particularly affects infants under 2 years.

The 2001 consensus conference and bronchiolitis 2006 on the management clarified the criteria for hospitalization and simplified therapeutic attitudes. These conferences have highlighted the importance of humidification, the nasopharyngeal desobstruction for less severe forms of oxygen therapy and for others. Recent literature has also shown that the use of noninvasive ventilation type CPAP (Continuous Positive Airway Pressure) nasal or broadband nasal glasses (HFNC: High Flow Nasal canula) in severe forms possible to reduce the work of breathing of children with severe bronchiolitis and their use in studies "before / after" was accompanied by a significant decrease in the use of invasive ventilation.

The HFNC and nasal CPAP can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. These devices generate a continuous positive pressure in the airways, for decreasing the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma, sometimes encountered with nasal CPAP interfaces.

The HFNC is a simple, effective and safe, commonly used in severe bronchiolitis admitted in ICU (Intensive Care Unit). However instead of this technique is not yet well defined.

The investigators assume that the use of HFNC in severe bronchiolitis in first line allows sufficient respiratory improvement to avoid recourse to other technical assistance ventilatory more binding.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Using Nasal Broadband Glasses HFNC (High Flow Nasal Cannula) in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU: Bicentric Observational Study on the 2013-2014 Epidemic
Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arms and Interventions
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Arm Intervention/treatment
High Flow Nasal Cannula
Use of High Flow Nasal Cannula
 Other: High Flow Nasal Cannula
Evaluation of the use of High Flow Nasal Cannula by biological marqers, questionnary of quality of use of HFNC by the physician, questionnary of evaluation of adverse events with HFNC


Outcome Measures
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Primary Outcome Measures :
  1. Rate of early success for the number of bronchiolitis who once admitted in the ICU and placed HFNC will not need another support ventilation mode after one hour of treatment (H1) [ Time Frame: after one hour of treatment ]
    the number of children who once set HFNC at baseline Hour 0 will not need another breathing assistance technique After 1 hour H1 of treatment


Secondary Outcome Measures :
  1. Overall success rate [ Time Frame: Comparaison between baseline Hour 0 and after 1 hour of treatment ]
    Number of children who will not need another technique while respiratory assistance throughout the ICU stay

  2. Predictive factors of failure of HFNC [ Time Frame: At baseline hour 0 ]
    Correlation of clinical and demographic data H0 to failure of HFNC

  3. The child's comfort HFNC [ Time Frame: comparison to H0, H1, H12 ]
    EDEN (pain scale and discomfort newborn) comfort Scores comparison to H0, H1, H12

  4. Incidence of adverse events in HFNC [ Time Frame: From baseline hour 0 to the end of hospitalization ]
    Frequency and types of adverse events throughout the ICU hospitalization period

  5. Effectiveness of HFNC on reducing the work of breathing after 1 hour [ Time Frame: Comparaison between baseline Hour 0 and after 1 hour of treatment ]
    H0 and H1 evaluation criteria for assessing the change in clinical status including respiratory work HFNC


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In which the diagnosis of bronchiolitis is strongly suspected (1st or nth episode). Acute bronchiolitis is defined by the presence of respiratory distress (wheezing, crackles ausculatory, wrestling signs) or apnea can not be explained by another existing pathology in children with a clinical history of upper respiratory infection.
  • Satisfactory at least 1 of the following severity criteria:

EN> 50 quiet, Trouble consciousness / hypotonia, Significant Apnea (with desaturation and / or bradycardia) Hypercapnic acidosis (pH <7.3 and PCO2> 55mmHg) SpO2 <92% on room air

  • Including the holders of parental authority / legal representative are informed of the study and expressed no opposition to the participation of their child.
  • Affiliated with a social security scheme by one of the holders of parental authority / legal guardian

Exclusion Criteria:

  • Children with neuromuscular disease known heart or lung (even without decompensation) at the time of admission.
  • Any vital distress, including respiratory or neurological justifying intubation or other emergency resuscitation gesture.
  • Opposition to a parent / guardian to the participation of their children in the study.
  • Desire to study withdrawal expressed by one of the holders of parental authority / legal guardian
  • Voluntary or involuntary break current care protocol or research by the healthcare team.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791711


Locations
France
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, France, 34295
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, France, 06200
Sponsors and Collaborators
Fondation Lenval
Investigators
Principal Investigator: Mickael AFANETTI, MD Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
More Information
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT02791711     History of Changes
Other Study ID Numbers: 14-HPNCL-09
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fondation Lenval:
Bronchiolitis
Continuous Positive Airway Pressure
HFNC

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections