ClinicalTrials.Veeva

Menu

High Flow Nasal Cannula in Children With Status Asthmaticus (CANULASTHM)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Status Asthmaticus

Treatments

Device: HFNC
Device: Standard Oxygen Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03157102
69HCL17_0035
IDRCB (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

272 patients

Sex

All

Ages

6 months to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

272 participants in 2 patient groups

HFNC group
Experimental group
Treatment:
Device: HFNC
Standard Oxygen Therapy group (STO group)
Other group
Treatment:
Device: Standard Oxygen Treatment

Trial contacts and locations

14

Loading...

Central trial contact

Robin Pouyau, Dr; Tiphanie Ginhoux

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems