Asthma AcuteNCT04033666
Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation
A study testing High Flow Nasal cannula and NIV Noninvasive Ventilation in people with Asthma Acute, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This study compares two types of noninvasive treatments for asthma attacks with the objective of analyzing the efficacy of each therapy during the period of exacerbations in infants and asthmatics hospitalized. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Asthma Acute
- What is being tested?
- High Flow Nasal cannula and NIV Noninvasive Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2019to 30 Nov 2019
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 5 and 16 years;
- both genders;
- Be in the presence of the bronchospasm crisis;
- Be admitted to HICF Hospital;
- Have signed the search terms
Who cannot join
- Having associated heart disease;
- neurological/cognitive impairment;
- Have severe respiratory insufficiency detected by severity scores;
- Intolerance to any type of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation in Acute Asthmatic Children
This study compares two types of noninvasive treatments for asthma attacks with the objective of analyzing the efficacy of each therapy during the period of exacerbations in infants and asthmatics hospitalized.
Read the detailed description
A randomized clinical trial, where it will be established, treatment in hospitalized asthma patients in the infirmary and Emergency Room of the Hospital Infantil Cândido Fontoura.
The children eligible for the Protocol, after signing the terms of consent and assent, will be randomized for treatment in 2 groups (GI - bilevel and GII - High Flow Nasal Cannula). After the evaluations are started: Feb1, Volume expired in the first second; Peak Flow, vital signs and calculated Pulmonary Asthma Score, Pulmonary Asthma Severity Score, Pulmonary Index Score, and therapy application. The N to be considered for the study of 20 individuals per group. Group therapy I will be applied in diaphragmatic re-education exercises 3 x 10 breaths, after non-invasive ventilation, with parameters 12 cm H2O Ipap and Epap 8 cm H2O, for 45 minutes, according to patient tolerance, interface, with full face mask After treatment, reassessment of vital signs and measurements of Peak Flow, Fev1 and Severity Scores.
The GII will be established therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight and respiratory rate at the time of evaluation, ranging from 2 l / min to 30 l / min. flow. The therapy will begin with diaphragmatic exercises 3 x 10 breaths, after 45 minutes of the installation of the therapy that is continuous, will be performed a reassessment of vital signs and Peak Flow, Feb, Severity Scores.
During the hospitalization time of the child will be carried out the daily treatment, therapy chosen for each patient for 45 minutes in the case of GI and the GII group daily follow-up and adjustment of flow dosage, also evaluated the vital signs, vital signs and Peak Flow, Feb, Gravity Scores.
At the time of hospital discharge, the evaluations will be performed and data such as inhaled corticosteroid use, oxygen use in days and inspired fraction, hospitalization days, hospital costs, as well as vital signs, vital signs and Peak Flow, Fev, Scores of Gravity.
- Conditions
- Asthma Acute
- Being tested
- High Flow Nasal cannula, NIV Noninvasive Ventilation
- Keywords
- asthma, High flow nasal cannula, Non invasive ventilation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal cannulaOther
Also called HFNC
The HFNC will be instituted therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight, ranging from 2 l / min to 30 l / min. The therapy will begin with diaphragmatic exercises 3x10 breaths and after high-flow therapy with nasal cannula for 45 minutes, after which will be performed the vital signs evaluations and Peak Flow, HRV, FEV1.
NIV Noninvasive VentilationOther
Also called NIV
The Therapy consisted of 3x10 diaphragmatic re-education exercises after a Bipap device was coupled in bipedal mode with parameters Ipap 12 cm H2O and Epap 8 cm H2O, for 45 minutes, according to the patient's tolerance, with Full face facial mask. After therapy evaluated vital signs and measures of Peak Flow, HRV, FEV1.
| Study group | Role | What they receive |
|---|---|---|
| High Flow nasal cannula | Active comparator | It will be administered as part of the high-flow nasal cannula treatment to reduce the symptoms of acute asthma Receives: Other: High Flow Nasal cannula |
| NIV noninvasive ventilation | Active comparator | It will be administered as part of the Noninvasive ventilation treatment to reduce the symptoms of acute asthma Receives: Other: NIV Noninvasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAS Pediatric Asthma Score
PAS Pediatric Asthma Score- This score assesses respiratory distress and wheezing. Higher score the more severe the asthma attack. The score ranges from 3 to 15 and clinical improvement is expected when there is a reduction of 3 points or more.
Measured: Change from baseline PAS at first 45 minutes and 5th day in hospital
Suplemental Oxigen day use
Oxigen dose number of days used
Measured: Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.
Secondary outcomes (2)
Forced Expiratory volume in first second
FEV1 liters and percentage
Measured: Change from baseline FEV1 at first 45 minutes and 5th day in hospital.
Bronchodilator doses ( Salbutamol)
Amount of puffs administered per day
Measured: Change from baseline Salbutamol dose (First day and 5th day in hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start10 Jan 2019
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- 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
- Model description
- This is a randomized clinical trial comparing high-flow nasal cannula intervention with non-invasive ventilation with two levels of pressure in children hospitalized for acute asthma
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelim Leal de Freitas Dantas Gomes, PT, University of Nove de Julho
- Investigators
- Dirceu Costa, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033666
- Sponsor's protocol ID
- High Flow Nasal Cannula
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
David MMC, Gomes ELFD, Cavassini CLF, Luiz JG, Costa D. Comparison of the effects of high-flow nasal cannula and bilevel positive airway pressure treatments as respiratory physiotherapy interventions for children with asthma exacerbation: a randomized clinical trial. Einstein (Sao Paulo). 2024 Aug 26;22:eAO0588. doi: 10.31744/einstein_journal/2024AO0588. eCollection 2024.
PubMed 39194097
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation in Acute Asthmatic Children
- ClinicalTrials.gov ID
- NCT04033666
- Acronym / sponsor ID
- High Flow Nasal Cannula
- Conditions
- Asthma Acute
- Keywords
- asthma, High flow nasal cannula, Non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 26 Jul 2019 (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.
This study compares two types of noninvasive treatments for asthma attacks with the objective of analyzing the efficacy of each therapy during the period of exacerbations in infants and asthmatics hospitalized.
Detailed description
A randomized clinical trial, where it will be established, treatment in hospitalized asthma patients in the infirmary and Emergency Room of the Hospital Infantil Cândido Fontoura.
The children eligible for the Protocol, after signing the terms of consent and assent, will be randomized for treatment in 2 groups (GI - bilevel and GII - High Flow Nasal Cannula). After the evaluations are started: Feb1, Volume expired in the first second; Peak Flow, vital signs and calculated Pulmonary Asthma Score, Pulmonary Asthma Severity Score, Pulmonary Index Score, and therapy application. The N to be considered for the study of 20 individuals per group. Group therapy I will be applied in diaphragmatic re-education exercises 3 x 10 breaths, after non-invasive ventilation, with parameters 12 cm H2O Ipap and Epap 8 cm H2O, for 45 minutes, according to patient tolerance, interface, with full face mask After treatment, reassessment of vital signs and measurements of Peak Flow, Fev1 and Severity Scores.
The GII will be established therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight and respiratory rate at the time of evaluation, ranging from 2 l / min to 30 l / min. flow. The therapy will begin with diaphragmatic exercises 3 x 10 breaths, after 45 minutes of the installation of the therapy that is continuous, will be performed a reassessment of vital signs and Peak Flow, Feb, Severity Scores.
During the hospitalization time of the child will be carried out the daily treatment, therapy chosen for each patient for 45 minutes in the case of GI and the GII group daily follow-up and adjustment of flow dosage, also evaluated the vital signs, vital signs and Peak Flow, Feb, Gravity Scores.
At the time of hospital discharge, the evaluations will be performed and data such as inhaled corticosteroid use, oxygen use in days and inspired fraction, hospitalization days, hospital costs, as well as vital signs, vital signs and Peak Flow, Fev, Scores of Gravity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial comparing high-flow nasal cannula intervention with non-invasive ventilation with two levels of pressure in children hospitalized for acute asthma
| Arm | Type | Receives |
|---|---|---|
| High Flow nasal cannula | Active comparator | Other: High Flow Nasal cannulaIt will be administered as part of the high-flow nasal cannula treatment to reduce the symptoms of acute asthma |
| NIV noninvasive ventilation | Active comparator | Other: NIV Noninvasive VentilationIt will be administered as part of the Noninvasive ventilation treatment to reduce the symptoms of acute asthma |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 5 and 16 years;
- both genders;
- Be in the presence of the bronchospasm crisis;
- Be admitted to HICF Hospital;
- Have signed the search terms
Key exclusion criteria (4 listed)
- Having associated heart disease;
- neurological/cognitive impairment;
- Have severe respiratory insufficiency detected by severity scores;
- Intolerance to any type of treatment
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 |
|---|---|---|
| High Flow Nasal cannulaAlso: HFNCThe HFNC will be instituted therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight, ranging from 2 l / min to 30 l / min. The therapy will begin with diaphragmatic exercises 3x10 breaths and after high-flow therapy with nasal cannula for 45 minutes, after which will be performed the vital signs evaluations and Peak Flow, HRV, FEV1. | Other | High Flow nasal cannula |
| NIV Noninvasive VentilationAlso: NIVThe Therapy consisted of 3x10 diaphragmatic re-education exercises after a Bipap device was coupled in bipedal mode with parameters Ipap 12 cm H2O and Epap 8 cm H2O, for 45 minutes, according to the patient's tolerance, with Full face facial mask. After therapy evaluated vital signs and measures of Peak Flow, HRV, FEV1. | Other | NIV noninvasive ventilation |
Primary outcome
PAS Pediatric Asthma Score
Time frame: Change from baseline PAS at first 45 minutes and 5th day in hospital
PAS Pediatric Asthma Score- This score assesses respiratory distress and wheezing. Higher score the more severe the asthma attack. The score ranges from 3 to 15 and clinical improvement is expected when there is a reduction of 3 points or more.
Suplemental Oxigen day use
Time frame: Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.
Oxigen dose number of days used
2 secondary outcomes
Forced Expiratory volume in first second
Time frame: Change from baseline FEV1 at first 45 minutes and 5th day in hospital.
Bronchodilator doses ( Salbutamol)
Time frame: Change from baseline Salbutamol dose (First day and 5th day in hospital)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Derived from this study: PubMed 39194097David MMC, Gomes ELFD, Cavassini CLF, Luiz JG, Costa D. Comparison of the effects of high-flow nasal cannula and bilevel positive airway pressure treatments as respiratory physiotherapy interventions for children with asthma exacerbation: a randomized clinical trial. Einstein (Sao Paulo). 2024 Aug 26;22:eAO0588. doi: 10.31744/einstein_journal/2024AO0588. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Asthma Acute
Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
Asthma Acute
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingPhase 2
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
Asthma Acute, Asthma Attack
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
Active, not recruiting
Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design
Asthma in Children
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.
Dirceu Costa principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal cannula and NIV Noninvasive Ventilation in people with Asthma Acute, run by University of Nove de Julho at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
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?
PAS Pediatric Asthma Score (time frame: Change from baseline PAS at first 45 minutes and 5th day in hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033666, which also lists 1 linked publication.
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 Jul 2019.