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Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common diagnoses in children admitted to pediatric intensive care unit.
Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on HFNC and HFNC with ENDs.
Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Children's Hospital due to acute respiratory failure secondary to bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory parameters will be collected as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.
Acute respiratory failure secondary to bronchiolitis is one of the most common diagnoses in children admitted to pediatric intensive care unit.
Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on high flow nasal cannula (HFNC) and HFNC with an external nasal dilator (END).
Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Children's Hospital between July 2015 and May 2017 for approximately 22 months due to acute respiratory failure secondary to bronchiolitis are eligible for inclusion in the study. Two arms will be studied, one with HFNC and the other with HFNC and ENDS. Modified Bronchiolitis Severity Score will be used to assess respiratory parameters as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow nasal cannula (HFNC) | Active Comparator | Non-invasive positive pressure ventilation |
|
| HFNC and external nasal dilator (END) | Experimental | high flow nasal cannula and external nasal dilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External nasal dilator (END) | Device | Applying External nasal dilator as adjuvant to high flow oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone | Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status) | Change from baseline to time of hospital discharge, no greater than 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU | Actual length of stay in pediatric ICU from admission to discharge | From subject enrollment to hospital discharge, not >170 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janeth Ejike, MD | Loma Linda University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLUCH | Loma Linda | California | 92374 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Flow Nasal Cannula (HFNC) | Non-invasive positive pressure ventilation High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27 |
| FG001 | HFNC and External Nasal Dilator (END) | high flow nasal cannula and external nasal dilator External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Flow Nasal Cannula (HFNC) | Non-invasive positive pressure ventilation High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27 |
| BG001 | HFNC and External Nasal Dilator (END) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone | Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status) | Posted | Mean | Full Range | number/score | Change from baseline to time of hospital discharge, no greater than 1 month |
|
Time period between between subject enrollment to hospital discharge not more than 1month
None in both groups
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Flow Nasal Cannula (HFNC) | Non-invasive positive pressure ventilation High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janeth Ejike | Loma Linda University Children's Hospital | 9095584000 | 44250 | jejike@llu.edu |
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| High flow nasal cannula (HFNC) | Other | Non-invasive positive pressure ventilation |
|
high flow nasal cannula and external nasal dilator
External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 28
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | High Flow Nasal Cannula (HFNC) | Non-invasive positive pressure ventilation High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Higher MBSS |
| OG001 | HFNC and External Nasal Dilator (END) | high flow nasal cannula and external nasal dilator External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Lower MBSS |
|
|
| Secondary | Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU | Actual length of stay in pediatric ICU from admission to discharge | Posted | Median | Full Range | hours | From subject enrollment to hospital discharge, not >170 hr |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | HFNC and External Nasal Dilator (END) | high flow nasal cannula and external nasal dilator External nasal dilator (END): Applying External nasal dilator as adjuvant to high flow oxygen High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation No adverse events | 0 | 28 | 0 | 28 | 0 | 28 |
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