High Flow Nasal Cannula in Children With Status Asthmaticus

NCT ID: NCT03157102

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2023-06-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HFNC group

Group Type: EXPERIMENTAL

HFNC

Intervention Type: 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). .

Standard Oxygen Therapy group (STO group)

Group Type: OTHER

Standard Oxygen Treatment

Intervention Type: 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.

Interventions

HFNC

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). .

Intervention Type: DEVICE

Standard Oxygen Treatment

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Pouyau, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Femme-Mère-Enfant

Bron, , France

CHU de Dijon

Dijon, , France

CHU de Grenoble Alpes

Grenoble, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Hôpital Timone 2

Marseille, , France

CH Annecy Genevois

Metz-Tessy, , France

CHU Arnaud de Villeneuve

Montpellier, , France

CHU de Nantes

Nantes, , France

Chu Lenval

Nice, , France

Hôpital Armand Trousseau

Paris, , France

Hôpital Necker Enfants Malades

Paris, , France

Hôpital Robert Debré

Paris, , France

CHU Strasbourg,

Strasbourg, , France

CH Villefranche sur Saône,

Villefranche-sur-Saône, , France

Countries

France

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0035

Identifier Type: -

Identifier Source: org_study_id