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

• ClinicalTrials.gov Identifier: NCT02791711
• Recruitment Status: Completed
• First Posted: June 7, 2016
• Last Update Posted: August 1, 2019
• Sponsor: Fondation Lenval
• Information provided by (Responsible Party): Fondation Lenval

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.

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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

Arms and Interventions

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 markers, questionary of quality of use of HFNC by the physician, questionary of evaluation of adverse events with HFNC

Outcome Measures

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: Comparison 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. Demographic predictive factors of failure of HFNC [ Time Frame: At baseline hour 0 ]
   Correlation of demographic data Hour 0 to failure of HFNC
3. Clinical predictive factors of failure of HFNC [ Time Frame: At baseline hour 0 ]
   Correlation of clinical data Hour 0 to failure of HFNC
4. The child's comfort HFNC [ Time Frame: comparison to Hour 0, Hour 1, Hour 12 ]

   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.

5. 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
6. Effectiveness of HFNC after 1 hour of application [ Time Frame: Comparison between baseline Hour 0 and after 1 hour of treatment ]
   comparaison of clinical data between baseline and 1 Hour of HFNC application.

Eligibility Criteria

• 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 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.

Contacts and Locations

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

• Responsible Party: Fondation Lenval
• ClinicalTrials.gov Identifier: NCT02791711
• Other Study ID Numbers: 14-HPNCL-09
• First Posted: June 7, 2016
• Last Update Posted: August 1, 2019
• 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