Acute Respiratory Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExternal nasal dilator (END)
Applying External nasal dilator as adjuvant to high flow oxygen
Non-invasive positive pressure ventilation
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* children less than 18years * acute respiratory failure
Exclusion criteria
* immediate intubation * \>18years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 from baseline to time of hospital discharge, no greater than 1 month | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU | From subject enrollment to hospital discharge, not >170 hr | Actual length of stay in pediatric ICU from admission to discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Flow Nasal Cannula (HFNC) Non-invasive positive pressure ventilation
High flow nasal cannula (HFNC): Non-invasive positive pressure ventilation Subjects: 27 | 27 |
| 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 | 28 |
| Total | 55 |
Baseline characteristics
| Characteristic | HFNC and External Nasal Dilator (END) | Total | High Flow Nasal Cannula (HFNC) |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 55 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.36 months | 10.8 months | 10.31 months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) White | 24 Participants | 47 Participants | 23 Participants |
| Region of Enrollment United States | 28 participants | 55 participants | 27 participants |
| Sex: Female, Male Female | 15 Participants | 32 Participants | 17 Participants |
| Sex: Female, Male Male | 13 Participants | 23 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 27 | 0 / 28 |
Outcome results
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)
Time frame: Change from baseline to time of hospital discharge, no greater than 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Flow Nasal Cannula (HFNC) | 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 | 1 number/score |
| HFNC and External Nasal Dilator (END) | 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 | 10 number/score |
Secondary
Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU
Actual length of stay in pediatric ICU from admission to discharge
Time frame: From subject enrollment to hospital discharge, not >170 hr
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Flow Nasal Cannula (HFNC) | Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU | 73.5 hours |
| HFNC and External Nasal Dilator (END) | Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU | 93.5 hours |