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

NCT02791711 | Completed

• 1 other identifier: 14-HPNCL-09
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Continuous Positive Airway Pressure; HFNC

Outcome Measures

Primary Outcomes (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)

  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

  after one hour of treatment

Secondary Outcomes (6)

• Overall success rate

  Comparison between baseline Hour 0 and after 1 hour of treatment

• Demographic predictive factors of failure of HFNC

  At baseline hour 0

• Clinical predictive factors of failure of HFNC

  At baseline hour 0

• The child's comfort HFNC

  comparison to Hour 0, Hour 1, Hour 12

• Incidence of adverse events in HFNC

  From baseline hour 0 to the end of hospitalization

Study Arms (1)

High Flow Nasal Cannula

OTHER

Use of High Flow Nasal Cannula

Other: High Flow Nasal Cannula

Interventions

High Flow Nasal Cannula OTHER

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

High Flow Nasal Cannula

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (2)

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, 34295, France

Location

Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Mickael AFANETTI, MD

  Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 7, 2016
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 1, 2019

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)