High Flow Nasal Cannula in Children With Status Asthmaticus

NCT03157102 | Completed DMC

• 2 other identifiers: 69HCL17_0035IDRCB
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 14

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).

Conditions

Status Asthmaticus

Keywords

children; status asthmaticus; HFNC

Outcome Measures

Primary Outcomes (1)

• Number of patients with first line treatment Failure as defined below in the first 24 hours

  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

  up to hour 24

Secondary Outcomes (10)

• 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 of noninvasive ventilation (NIV)

  month 1

• Comfort assessed by the FLACC score

  up to hour 24

Study Arms (2)

HFNC group

EXPERIMENTAL

Device: HFNC

Standard Oxygen Therapy group (STO group)

OTHER

Device: Standard Oxygen Treatment

Interventions

HFNC DEVICE

Oxygen therapy will be delivered through high flow nasal cannulas. Aerosol treatments will be administered through a vibrating mesh nebulizer directly connected to the circuit (aerogen®). The airvo® system (Fisher \& Peykel Healthcare, Auckland, New Zealand) will be used as the high flow cannula system in the study. Cannula size will be tailored to the child according to the manufacturer's recommendations. The gas flow will be adjusted according to the child's weight in a predefined chart. FiO2 will be adjusted to allow for a SpO2 \>92%. All the patients, regardless of their treatment failure status, will be evaluated at H2, H6, H12 and H24 to monitor their evolution (evaluation of the standard parameters, consciousness, PRAM (Pediatric Respiratory Assessment Measure) score, pain assessment by the FLACC (Face Legs Activity Cry Consolability) score). .

HFNC group

Standard Oxygen Treatment DEVICE

Children will receive supplemental oxygen as commonly delivered through a non-rebreather face mask or low flow nasal cannula (standard oxygen treatment) and beta2 agonist aerosol via vibrating mesh nebulizer (aerogen®) according to the procedures usually used in the unit and according to the GINA (Global Initiative for Asthma) protocol. This group is the standard treatment group and is therefore the control group. All the patients, regardless of their treatment failure status, will be evaluated at H2, H6, H12 and H24 to monitor their evolution (evaluation of the standard parameters, consciousness, PRAM score, pain assessment by the FLACC score). The use of adjuvant therapies (magnesium sulfate, salbutamol IVSE, and ipratropium bromide) will remain at the discretion of the physician in charge of the child and will be evaluated as a secondary criterion.

Standard Oxygen Therapy group (STO group)

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 6 months and \<18 years old
• Hospitalized in PICU with status asthmaticus defined by
• 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)
• or with hypercapnic acidosis (pCO2 \> 45 mmHg and pH \< 7,35)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (14)

Hôpital Femme-Mère-Enfant

Bron, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Grenoble Alpes

Grenoble, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital Timone 2

Marseille, France

Location

CH Annecy Genevois

Metz-Tessy, France

Location

CHU Arnaud de Villeneuve

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

Chu Lenval

Nice, France

Location

Hôpital Armand Trousseau

Paris, France

Location

Hôpital Necker Enfants Malades

Paris, France

Location

Hôpital Robert Debré

Paris, France

Location

CHU Strasbourg,

Strasbourg, France

Location

CH Villefranche sur Saône,

Villefranche-sur-Saône, France

Location

MeSH Terms

Conditions

Status Asthmaticus

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robin Pouyau, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 17, 2017
• Study Start: August 8, 2018
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)