Clinical trial NCT03157102: High Flow Nasal Cannula in Children With Status Asthmaticus
Official title: High Flow Nasal Cannula Versus Standard Oxygen Therapy in Children With Status Asthmaticus: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Status Asthmaticus
Keywords: children
status asthmaticus
HFNC
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 272
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with first line treatment Failure as defined below in the first 24 hours
timeFrame: up to hour 24
Secondary outcomes:
measure: Number of Patients requiring noninvasive ventilation (NIV)
timeFrame: month 1
measure: Number of Patients requiring invasive ventilation (IV).
timeFrame: month 1
measure: Duration of invasive ventilation (IV).
timeFrame: month 1
measure: Duration of noninvasive ventilation (NIV)
timeFrame: month 1
measure: Comfort assessed by the FLACC score
timeFrame: up to hour 24
measure: Duration of supplemental oxygen therapy (in hours)
timeFrame: month 1
measure: Time from inclusion to restoration of a PRAM score < 8 (in hours).
timeFrame: month 1
measure: Time from inclusion to blood gas normalization (pCO2<45 mmHg and pH>7.35) if available (hours)
timeFrame: month 1
measure: Cumulative dose of treatments (salbutamol, corticosteroid magnesium sulfate)
timeFrame: month 1
measure: total number of hours of PICU stay
timeFrame: month 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
city: Marseille
country: France
facility: Hôpital Timone 2
city: Metz-Tessy
country: France
facility: CH Annecy Genevois
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: Chu Lenval
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Debré
city: Strasbourg,
country: France
facility: CHU Strasbourg,
city: Villefranche sur Saône
country: France
facility: CH Villefranche sur Saône,
Study officials:
affiliation: Hospices Civils de Lyon
name: Robin Pouyau, Dr
role: PRINCIPAL_INVESTIGATOR
References: