Non-invasive VentilationNCT03859947
High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis
An observational study of Non-invasive Ventilation and Pediatric Pulmonary Disease, run by Ali Yurtseven at 1 site in Turkey (Türkiye).
Trial summary
Objective: The investigators aimed to compare the heated humidified high-flow nasal cannula (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe bronchiolitis presenting to the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 1 day to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Ventilation, Pediatric Pulmonary Disease
- What is being tested?
- Heated humidified high-flow nasal cannula
- Type of treatment
- Medical device
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2017to 31 Oct 2018
- Phase
- Observational
- 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 1 day to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All patients with a clinical diagnosis of severe bronchiolitis, aged less than 24 months and presenting to the emergency department
Who may be able to join
- Clinical diagnosis of severe bronchiolitis
- Must be less than 24 months
- Must have presented to the emergency department
Who cannot join
- Immediate invasive ventilation and/or intensive care unit admission
- Congenital heart disease,
- Chronic lung disease
- Neuromuscular disease
- Netabolic disease
- Craniofacial anomalies
Show all 10Show fewer
- Immunocompromised
- Bacterial pneumonia
- Pneumothorax
- Nasal trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine, Pediatric Emergency Department
Izmir, 35100
About this study
Official title: Comparison of Heated humidified High-flow Nasal Cannula Flow Rates (1-L/kg/Min vs 2-L/kg/Min) in the Management of Severe Bronchiolitis
Objective: The investigators aimed to compare the heated humidified high-flow nasal cannula (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe bronchiolitis presenting to the pediatric emergency department.
Study design: The investigators performed a study in which all patients were allocated to receive these two flow rates. The primary outcome was admitted as treatment failure, which was defined as a clinical escalation in respiratory status. Secondary outcomes covered a decrease of respiratory rate (RR), heart rate (HR), the clinical respiratory score (CRS), rise of peripheral capillary oxygen saturation (SpO2) and rates of weaning, intubation and intensive care unit (ICU) admission.
Keywords: Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate
- Being tested
- Heated humidified high-flow nasal cannula
- Keywords
- Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate
- Medical subject headings
- Bronchiolitis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated humidified high-flow nasal cannulaDevice
Non-invasive ventilation with a nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute bronchiolitis | Not described Receives: Device: Heated humidified high-flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate
We compared the treatment failure between the 1-L/kg/min flow rate with 2-L/kg/min rate in patients with severe bronchiolitis
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start10 May 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Yurtseven
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Sponsor-investigator, Ali Yurtseven, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859947
- Sponsor's protocol ID
- 2.100.2017.0025
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Heated humidified High-flow Nasal Cannula Flow Rates (1-L/kg/Min vs 2-L/kg/Min) in the Management of Severe Bronchiolitis
- ClinicalTrials.gov ID
- NCT03859947
- Acronym / sponsor ID
- 2.100.2017.0025
- Keywords
- Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ali YurtsevenUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 10 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 1 Mar 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.
Objective: The investigators aimed to compare the heated humidified high-flow nasal cannula (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe bronchiolitis presenting to the pediatric emergency department.
Study design: The investigators performed a study in which all patients were allocated to receive these two flow rates. The primary outcome was admitted as treatment failure, which was defined as a clinical escalation in respiratory status. Secondary outcomes covered a decrease of respiratory rate (RR), heart rate (HR), the clinical respiratory score (CRS), rise of peripheral capillary oxygen saturation (SpO2) and rates of weaning, intubation and intensive care unit (ICU) admission.
Keywords: Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute bronchiolitis | – | Device: Heated humidified high-flow nasal cannula |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All patients with a clinical diagnosis of severe bronchiolitis, aged less than 24 months and presenting to the emergency department
Key inclusion criteria (3 listed)
- Clinical diagnosis of severe bronchiolitis
- Must be less than 24 months
- Must have presented to the emergency department
Key exclusion criteria (10 listed)
- Immediate invasive ventilation and/or intensive care unit admission
- Congenital heart disease,
- Chronic lung disease
- Neuromuscular disease
- Netabolic disease
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 |
|---|---|---|
| Heated humidified high-flow nasal cannulaNon-invasive ventilation with a nasal cannula | Device | Patients with acute bronchiolitis |
Primary outcome
Treatment failure rate
Time frame: Within 24 hours
We compared the treatment failure between the 1-L/kg/min flow rate with 2-L/kg/min rate in patients with severe bronchiolitis
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 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Ventilation and Pediatric Pulmonary Disease, run by Ali Yurtseven at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 Mar 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 Turkey (Türkiye). 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?
Treatment failure rate (time frame: Within 24 hours). 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 Mar 2019.