Status AsthmaticusCANULASTHMNCT03157102
High Flow Nasal Cannula in Children With Status Asthmaticus
A study testing HFNC and Standard Oxygen Treatment in people with Status Asthmaticus, run by Hospices Civils de Lyon at 14 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- HFNC and Standard Oxygen Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 14 sitesFrance
- Study dates
- 8 Aug 2018to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
- Informed consent signed by at least on parent or legal guardians prior to inclusion and oral consent of the other parent if absent
Who cannot join
- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Hôpital Femme-Mère-Enfant
Bron
CHU de Dijon
Dijon
CHU de Grenoble Alpes
Grenoble
Hôpital Bicêtre
Le Kremlin-Bicêtre
Hôpital Timone 2
Marseille
CH Annecy Genevois
Metz-Tessy
CHU Arnaud de Villeneuve
Montpellier
CHU de Nantes
Nantes
Chu Lenval
Nice
Hôpital Armand Trousseau
Paris
Hôpital Necker Enfants Malades
Paris
Hôpital Robert Debré
Paris
CHU Strasbourg,
Strasbourg
CH Villefranche sur Saône,
Villefranche-sur-Saône
About this study
Official title: High Flow Nasal Cannula Versus Standard Oxygen Therapy in Children With Status Asthmaticus: a Randomized Controlled Trial
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
- Being tested
- HFNC, Standard Oxygen Treatment
- Keywords
- children, status asthmaticus, HFNC
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
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 TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HFNC group | Experimental | Not described Receives: Device: HFNC |
| Standard Oxygen Therapy group (STO group) | Other | Not described Receives: Device: Standard Oxygen Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to hour 24
Secondary outcomes (10)
Number of Patients requiring noninvasive ventilation (NIV)
Measured: month 1
Number of Patients requiring invasive ventilation (IV).
Measured: month 1
Duration of invasive ventilation (IV).
Duration in hours
Measured: month 1
Duration of noninvasive ventilation (NIV)
Duration in hours
Measured: month 1
Comfort assessed by the FLACC score
Measured: up to hour 24
Duration of supplemental oxygen therapy (in hours)
Measured: month 1
Time from inclusion to restoration of a PRAM score < 8 (in hours).
Measured: month 1
Time from inclusion to blood gas normalization (pCO2<45 mmHg and pH>7.35) if available (hours)
Measured: month 1
Cumulative dose of treatments (salbutamol, corticosteroid magnesium sulfate)
in milligram during PICU stay
Measured: month 1
total number of hours of PICU stay
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start8 Aug 2018
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status AsthmaticusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Pouyau, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157102
- Sponsor's protocol ID
- 69HCL17_0035
- Other IDs
- IDRCB
- Acronym
- CANULASTHM
- Status last verified
- Sep 2023
- First submitted
- 2 May 2017
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus Standard Oxygen Therapy in Children With Status Asthmaticus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03157102
- Acronym / sponsor ID
- CANULASTHM / 69HCL17_0035
- Conditions
- Status Asthmaticus
- Keywords
- children, status asthmaticus, HFNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC group | Experimental | Device: HFNC |
| Standard Oxygen Therapy group (STO group) | Other | Device: Standard Oxygen Treatment |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≥ 6 months and <18 years old
- Hospitalized in PICU with status asthmaticus defined by
- Informed consent signed by at least on parent or legal guardians prior to inclusion and oral consent of the other parent if absent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNCOxygen 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). . | Device | HFNC group |
| Standard Oxygen TreatmentChildren 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. | Device | Standard Oxygen Therapy group (STO group) |
Primary outcome
Number of patients with first line treatment Failure as defined below in the first 24 hours
Time frame: 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
10 secondary outcomes
Number of Patients requiring noninvasive ventilation (NIV)
Time frame: month 1
Number of Patients requiring invasive ventilation (IV).
Time frame: month 1
Duration of invasive ventilation (IV).
Time frame: month 1
Duration of noninvasive ventilation (NIV)
Time frame: month 1
Comfort assessed by the FLACC score
Time frame: up to hour 24
Duration of supplemental oxygen therapy (in hours)
Time frame: month 1
Time from inclusion to restoration of a PRAM score < 8 (in hours).
Time frame: month 1
Time from inclusion to blood gas normalization (pCO2<45 mmHg and pH>7.35) if available (hours)
Time frame: month 1
Cumulative dose of treatments (salbutamol, corticosteroid magnesium sulfate)
Time frame: month 1
total number of hours of PICU stay
Time frame: month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Pouyau, Dr principal investigator
Hospices Civils de Lyon
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and Standard Oxygen Treatment in people with Status Asthmaticus, run by Hospices Civils de Lyon at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with first line treatment Failure as defined below in the first 24 hours (time frame: up to hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.