High Flow Nasal Cannula in Children With Status Asthmaticus

Not Applicable

Completed

Brief Summary: In France, over 2.5 million people suffer from asthma, including one-third of children. This is the chronic respiratory disease leading to the highest rate of hospitalization. The conventional oxygen delivery means in children are the non-rebreather face mask or low flow nasal cannula (standard oxygen therapy - SOT). New non-invasive ventilatory support systems such as High Flow Nasal Cannula (HFNC) are emerging. These are nasal cannulas allowing the delivery of a high air (or oxygen) flow, exceeding the inspiratory flow of patients with acute respiratory failure, allowing to deliver a slight positive expiratory pressure while ensuring humidification and warming of the airways. Aerosol administration is also possible with excellent efficiency and without interrupting respiratory assistance. Physiological data and clinical studies in other pathologies suggest the interest of this technique during the asthma attack, but no comparative study currently exists in this indication. The HFNCs could have their place upstream of Non Invasive Ventilation (NIV), thus replacing non-rebreather face mask sometimes not tolerated by the children. The investigators's hypothesis is that HFNCs could improve patients' health faster, reduce the use of other ventilatory assistance (NIV, invasive ventilation) and reduce the duration of hospitalization in intensive care units or continuous monitoring units (CMU).

Recruitment & Eligibility

Inclusion Criteria

Age ≥ 6 months and <18 years old
Hospitalized in PICU with status asthmaticus defined by
1. a PRAM score > 7 with no response at H2 to the conventional treatment according to the GINA (Global Initiative for Asthma guidelines) protocol: Oxygen therapy, Continuous nebulization of beta2 agonist for at least one hour then every hour, Oral or intravenous corticosteroid (ie methylprednisolone 2mg/kg/j)
2. or with hypercapnic acidosis (pCO2 > 45 mmHg and pH < 7,35)
Informed consent signed by at least on parent or legal guardians prior to inclusion and oral consent of the other parent if absent

Exclusion Criteria

Non-corrected congenital heart disease, or neuromuscular disease, or chronic respiratory disease (pulmonary or bronchial fibrosis, cystic fibrosis), or ENA disease (laryngo or tracheo malacia), scoliosis or chronic metabolic disease
Need for non-invasive or invasive ventilation (Glasgow comas scale <8, hemodynamic instability, refractory hypoxemia, cardiac arrest)
Pneumothorax confirmed on the X-ray
No national health coverage

Arm && Interventions

Group	Intervention	Description
HFNC group	HFNC	-
Standard Oxygen Therapy group (STO group)	Standard Oxygen Treatment	-

Primary Outcome Measures

Name	Time	Method
Number of patients with first line treatment Failure as defined below in the first 24 hours	up to hour 24	First line treatment Failure in the first 24 hours is defined as: * Occurrence or worsening of hypercapnic acidosis (pH\<7.35 with pCO2\>45 mmHg) * Or worsening of PRAM score (\>=2 from baseline) * Or SpO2\<92% with maximal flow of oxygen depending on age in the group standard oxygen therapy or with FiO2 \> 60% associated with a flow between 1 and 3L/Kg/min in the HFNC group * Or occurrence or worsening of the level of consciousness with Glasgow coma scale \< 12 * Or the need of invasive or noninvasive ventilation (Glasgow coma scale\<8, hemodynamic instability, refractory hypoxemia) at any time during the first 24 hours

Secondary Outcome Measures

Name	Time	Method
total number of hours of PICU stay	month 1
Cumulative dose of treatments (salbutamol, corticosteroid magnesium sulfate)	month 1	in milligram during PICU stay
Number of Patients requiring noninvasive ventilation (NIV)	month 1
Number of Patients requiring invasive ventilation (IV).	month 1
Duration of invasive ventilation (IV).	month 1	Duration in hours
Duration of noninvasive ventilation (NIV)	month 1	Duration in hours
Comfort assessed by the FLACC score	up to hour 24
Time from inclusion to restoration of a PRAM score < 8 (in hours).	month 1
Time from inclusion to blood gas normalization (pCO2<45 mmHg and pH>7.35) if available (hours)	month 1
Duration of supplemental oxygen therapy (in hours)	month 1

Locations (14): Hôpital Bicêtre
🇫🇷
Le Kremlin Bicêtre, France
Hôpital Timone 2
🇫🇷
Marseille, France
Hôpital Femme-Mère-Enfant
🇫🇷
Bron, France
Hôpital Armand Trousseau
🇫🇷
Paris, France
Hôpital Robert Debré
🇫🇷
Paris, France
CHU de Dijon
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Dijon, France
CHU Arnaud de Villeneuve
🇫🇷
Montpellier, France
CHU Strasbourg,
🇫🇷
Strasbourg,, France
Hôpital Necker Enfants Malades
🇫🇷
Paris, France
CHU de Nantes
🇫🇷
Nantes, France
CH Annecy Genevois
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Metz-Tessy, France
Chu Lenval
🇫🇷
Nice, France
CH Villefranche sur Saône,
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Villefranche sur Saône, France
CHU de Grenoble Alpes
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Grenoble, France