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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bronchiolitis focused on measuring Bronchiolitis, Continuous Positive Airway Pressure, HFNC

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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 auscultatory, 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 carbon dioxide partial pressure (PCO2)> 55mmHg)
  • Oxygen saturation (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.

Sites / Locations

  • Hôpital Arnaud de Villeneuve - CHU de Montpellier
  • Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

High Flow Nasal Cannula

Arm Description

Use of High Flow Nasal Cannula

Outcomes

Primary Outcome Measures

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)
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

Overall success rate
Number of children who will not need another technique while respiratory assistance throughout the ICU stay
Demographic predictive factors of failure of HFNC
Correlation of demographic data Hour 0 to failure of HFNC
Clinical predictive factors of failure of HFNC
Correlation of clinical data Hour 0 to failure of HFNC
The child's comfort HFNC
Neonatal pain and discomfort scale " Échelle Douleur Inconfort Nouveau-Né" (EDIN)) Scores comparison to Hour 0, Hour 1, Hour 12 This scale evaluates the prolonged pain and discomfort of the child, an hetero assesor measures by 5 items about face, body, sleep, comfort and relationship. Each item scores from 0 to 5. 0 means no pain or discomfort symptoms and 5 means the maximum symptoms. Global score will be from 0 to 15.
Incidence of adverse events in HFNC
Frequency and types of adverse events throughout the ICU hospitalization period
Effectiveness of HFNC after 1 hour of application
comparaison of clinical data between baseline and 1 Hour of HFNC application.

Full Information

First Posted
June 1, 2016
Last Updated
July 29, 2019
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02791711
Brief Title
Using Nasal Broadband Glasses in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU
Acronym
HFNC
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 Continuous Positive Airway Pressure (CPAP) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Continuous Positive Airway Pressure, HFNC

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula
Arm Type
Other
Arm Description
Use of High Flow Nasal Cannula
Intervention Type
Other
Intervention Name(s)
High Flow Nasal Cannula
Intervention Description
Evaluation of the use of High Flow Nasal Cannula by biological markers, questionary of quality of use of HFNC by the physician, questionary of evaluation of adverse events with HFNC
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
after one hour of treatment
Secondary Outcome Measure Information:
Title
Overall success rate
Description
Number of children who will not need another technique while respiratory assistance throughout the ICU stay
Time Frame
Comparison between baseline Hour 0 and after 1 hour of treatment
Title
Demographic predictive factors of failure of HFNC
Description
Correlation of demographic data Hour 0 to failure of HFNC
Time Frame
At baseline hour 0
Title
Clinical predictive factors of failure of HFNC
Description
Correlation of clinical data Hour 0 to failure of HFNC
Time Frame
At baseline hour 0
Title
The child's comfort HFNC
Description
Neonatal pain and discomfort scale " Échelle Douleur Inconfort Nouveau-Né" (EDIN)) Scores comparison to Hour 0, Hour 1, Hour 12 This scale evaluates the prolonged pain and discomfort of the child, an hetero assesor measures by 5 items about face, body, sleep, comfort and relationship. Each item scores from 0 to 5. 0 means no pain or discomfort symptoms and 5 means the maximum symptoms. Global score will be from 0 to 15.
Time Frame
comparison to Hour 0, Hour 1, Hour 12
Title
Incidence of adverse events in HFNC
Description
Frequency and types of adverse events throughout the ICU hospitalization period
Time Frame
From baseline hour 0 to the end of hospitalization
Title
Effectiveness of HFNC after 1 hour of application
Description
comparaison of clinical data between baseline and 1 Hour of HFNC application.
Time Frame
Comparison between baseline Hour 0 and after 1 hour of treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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 auscultatory, 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 carbon dioxide partial pressure (PCO2)> 55mmHg) Oxygen saturation (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mickael AFANETTI, MD
Organizational Affiliation
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Arnaud de Villeneuve - CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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