BronchiolitisHFNCNCT02791711
Using Nasal Broadband Glasses in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU
A study testing High Flow Nasal Cannula in people with Bronchiolitis, run by Fondation Lenval at 2 sites in France.
Trial summary
The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU. Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- High Flow Nasal Cannula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2013to Dec 2014
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In which the diagnosis of bronchiolitis is strongly suspected (1st or nth episode). Acute bronchiolitis is defined by the presence of respiratory distress (wheezing, crackles auscultatory, wrestling signs) or apnea can not be explained by another existing pathology in children with a clinical history of upper respiratory infection.
- Satisfactory at least 1 of the following severity criteria:
- EN> 50 quiet,
- Trouble consciousness / hypotonia,
- Significant Apnea (with desaturation and / or bradycardia)
- Hypercapnic acidosis (pH <7.3 and carbon dioxide partial pressure (PCO2)> 55mmHg)
Show all 9Show fewer
- Oxygen saturation (SpO2) <92% on room air
- Including the holders of parental authority / legal representative are informed of the study and expressed no opposition to the participation of their child.
- Affiliated with a social security scheme by one of the holders of parental authority / legal guardian
Who cannot join
- Children with neuromuscular disease known heart or lung (even without decompensation) at the time of admission.
- Any vital distress, including respiratory or neurological justifying intubation or other emergency resuscitation gesture.
- Opposition to a parent / guardian to the participation of their children in the study.
- Desire to study withdrawal expressed by one of the holders of parental authority / legal guardian
- Voluntary or involuntary break current care protocol or research by the healthcare team.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, 34295
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, 06200
About this study
Official title: Using Nasal Broadband Glasses HFNC (High Flow Nasal Cannula) in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU: Bicentric Observational Study on the 2013-2014 Epidemic
The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.
Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. This device generates a continuous positive pressure in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma.
Read the detailed description
Bronchiolitis in infants is a common and potentially serious disease. It corresponds to an acute pulmonary disease and dyspnea usually viral (70 to 80% of Respiratory syncytial virus (RSV) in infants less than 1 year). It particularly affects infants under 2 years.
The 2001 consensus conference and bronchiolitis 2006 on the management clarified the criteria for hospitalization and simplified therapeutic attitudes. These conferences have highlighted the importance of humidification, the nasopharyngeal desobstruction for less severe forms of oxygen therapy and for others. Recent literature has also shown that the use of noninvasive ventilation type Continuous Positive Airway Pressure (CPAP) nasal or broadband nasal glasses (HFNC: High Flow Nasal canula) in severe forms possible to reduce the work of breathing of children with severe bronchiolitis and their use in studies "before / after" was accompanied by a significant decrease in the use of invasive ventilation.
The HFNC and nasal CPAP can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. These devices generate a continuous positive pressure in the airways, for decreasing the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma, sometimes encountered with nasal CPAP interfaces.
The HFNC is a simple, effective and safe, commonly used in severe bronchiolitis admitted in ICU (Intensive Care Unit). However instead of this technique is not yet well defined.
The investigators assume that the use of HFNC in severe bronchiolitis in first line allows sufficient respiratory improvement to avoid recourse to other technical assistance ventilatory more binding.
- Conditions
- Bronchiolitis
- Being tested
- High Flow Nasal Cannula
- Keywords
- Bronchiolitis, Continuous Positive Airway Pressure, HFNC
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaOther
Evaluation of the use of High Flow Nasal Cannula by biological markers, questionary of quality of use of HFNC by the physician, questionary of evaluation of adverse events with HFNC
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Other | Use of High Flow Nasal Cannula Receives: Other: High Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of early success for the number of bronchiolitis who once admitted in the ICU and placed HFNC will not need another support ventilation mode after one hour of treatment (H1)
the number of children who once set HFNC at baseline Hour 0 will not need another breathing assistance technique After 1 hour H1 of treatment
Measured: after one hour of treatment
Secondary outcomes (6)
Overall success rate
Number of children who will not need another technique while respiratory assistance throughout the ICU stay
Measured: Comparison between baseline Hour 0 and after 1 hour of treatment
Demographic predictive factors of failure of HFNC
Correlation of demographic data Hour 0 to failure of HFNC
Measured: At baseline hour 0
Clinical predictive factors of failure of HFNC
Correlation of clinical data Hour 0 to failure of HFNC
Measured: At baseline hour 0
The child's comfort HFNC
Neonatal pain and discomfort scale " Échelle Douleur Inconfort Nouveau-Né" (EDIN)) Scores comparison to Hour 0, Hour 1, Hour 12
This scale evaluates the prolonged pain and discomfort of the child, an hetero assesor measures by 5 items about face, body, sleep, comfort and relationship. Each item scores from 0 to 5. 0 means no pain or discomfort symptoms and 5 means the maximum symptoms.
Global score will be from 0 to 15.
Measured: comparison to Hour 0, Hour 1, Hour 12
Incidence of adverse events in HFNC
Frequency and types of adverse events throughout the ICU hospitalization period
Measured: From baseline hour 0 to the end of hospitalization
Effectiveness of HFNC after 1 hour of application
comparaison of clinical data between baseline and 1 Hour of HFNC application.
Measured: Comparison between baseline Hour 0 and after 1 hour of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickael AFANETTI, MD, Principal investigator, Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791711
- Sponsor's protocol ID
- 14-HPNCL-09
- Acronym
- HFNC
- Status last verified
- Jun 2016
- First submitted
- 1 Jun 2016
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Nasal Broadband Glasses HFNC (High Flow Nasal Cannula) in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU: Bicentric Observational Study on the 2013-2014 Epidemic
- ClinicalTrials.gov ID
- NCT02791711
- Acronym / sponsor ID
- HFNC / 14-HPNCL-09
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Continuous Positive Airway Pressure, HFNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Jun 2016 (estimated)
- 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.
The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.
Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. This device generates a continuous positive pressure in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma.
Detailed description
Bronchiolitis in infants is a common and potentially serious disease. It corresponds to an acute pulmonary disease and dyspnea usually viral (70 to 80% of Respiratory syncytial virus (RSV) in infants less than 1 year). It particularly affects infants under 2 years.
The 2001 consensus conference and bronchiolitis 2006 on the management clarified the criteria for hospitalization and simplified therapeutic attitudes. These conferences have highlighted the importance of humidification, the nasopharyngeal desobstruction for less severe forms of oxygen therapy and for others. Recent literature has also shown that the use of noninvasive ventilation type Continuous Positive Airway Pressure (CPAP) nasal or broadband nasal glasses (HFNC: High Flow Nasal canula) in severe forms possible to reduce the work of breathing of children with severe bronchiolitis and their use in studies "before / after" was accompanied by a significant decrease in the use of invasive ventilation.
The HFNC and nasal CPAP can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. These devices generate a continuous positive pressure in the airways, for decreasing the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma, sometimes encountered with nasal CPAP interfaces.
The HFNC is a simple, effective and safe, commonly used in severe bronchiolitis admitted in ICU (Intensive Care Unit). However instead of this technique is not yet well defined.
The investigators assume that the use of HFNC in severe bronchiolitis in first line allows sufficient respiratory improvement to avoid recourse to other technical assistance ventilatory more binding.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Other | Other: High Flow Nasal CannulaUse of High Flow Nasal Cannula |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- In which the diagnosis of bronchiolitis is strongly suspected (1st or nth episode). Acute bronchiolitis is defined by the presence of respiratory distress (wheezing, crackles auscultatory, wrestling signs) or apnea can not be explained by another existing pathology in children with a clinical history of upper respiratory infection.
- Satisfactory at least 1 of the following severity criteria:
- EN> 50 quiet,
- Trouble consciousness / hypotonia,
- Significant Apnea (with desaturation and / or bradycardia)
Key exclusion criteria (5 listed)
- Children with neuromuscular disease known heart or lung (even without decompensation) at the time of admission.
- Any vital distress, including respiratory or neurological justifying intubation or other emergency resuscitation gesture.
- Opposition to a parent / guardian to the participation of their children in the study.
- Desire to study withdrawal expressed by one of the holders of parental authority / legal guardian
- Voluntary or involuntary break current care protocol or research by the healthcare team.
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 CannulaEvaluation of the use of High Flow Nasal Cannula by biological markers, questionary of quality of use of HFNC by the physician, questionary of evaluation of adverse events with HFNC | Other | High Flow Nasal Cannula |
Primary outcome
Rate of early success for the number of bronchiolitis who once admitted in the ICU and placed HFNC will not need another support ventilation mode after one hour of treatment (H1)
Time frame: after one hour of treatment
the number of children who once set HFNC at baseline Hour 0 will not need another breathing assistance technique After 1 hour H1 of treatment
6 secondary outcomes
Overall success rate
Time frame: Comparison between baseline Hour 0 and after 1 hour of treatment
Demographic predictive factors of failure of HFNC
Time frame: At baseline hour 0
Clinical predictive factors of failure of HFNC
Time frame: At baseline hour 0
The child's comfort HFNC
Time frame: comparison to Hour 0, Hour 1, Hour 12
Incidence of adverse events in HFNC
Time frame: From baseline hour 0 to the end of hospitalization
Effectiveness of HFNC after 1 hour of application
Time frame: Comparison between baseline Hour 0 and after 1 hour of treatment
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 1 Aug 2019.
- 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.
Mickael AFANETTI, MD principal investigator
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
2 sites 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 in people with Bronchiolitis, run by Fondation Lenval at 2 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 9 inclusion and 5 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Rate of early success for the number of bronchiolitis who once admitted in the ICU and placed HFNC will not need another support ventilation mode after one hour of treatment (H1) (time frame: after one hour of treatment). 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 1 Aug 2019.