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

NCT ID: NCT02791711

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High Flow Nasal Cannula

Use of High Flow Nasal Cannula

Group Type: OTHER

High Flow Nasal Cannula

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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.

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickael AFANETTI, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Locations

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, , France

Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, , France

Countries

France

Other Identifiers

14-HPNCL-09

Identifier Type: -

Identifier Source: org_study_id