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The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen in children with bronchiolitis.
The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing, and 3) decrease length of hospital stay.
Bronchiolitis is the leading cause of acute respiratory illness and hospitalization in infants and young children. The mainstay of treatment is supportive care, which includes frequent nasal suctioning, intravenous fluid hydration, and supplemental oxygen for hypoxemia.
The airways normally heat and humidify inspired ambient air to core temperature amd 100% relative humidity at the carina. This environment, at core temperature, allows for optimal mucociliary clearance. Supplemental oxygen delivered via wall source is cold and dry, and does not reach core temperature and 100% humidity until some point distal to the carina, past the main bronchi. This presses on the lower respiratory tract to assist in heat and moisture exchange and thus decrease ciliary function. This, in combination with bronchiolitis, can impair mucociliary clearance.
Specific aim 1: Determine the effect of heated and humidified oxygen therapy on clinical improvement in children with bronchiolitis, based on Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR).
Specific aim 2: Determine the effect of heated and humidified oxygen therapy on length of hospital stay and duration of supplemental oxygen requirement in children with bronchiolitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard oxygen via nasal cannula | No Intervention | Standard therapy | |
| Heated and humidified oxygen | Active Comparator | Heated and humified oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated and humidified oxygen | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module. | Baseline, Hour 1, Hour 4, Hour 8, and Hour 12 |
| Change in Respiratory Rate (RR) From Baseline | Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module. | Baseline, Hour 1, Hour 4, Hour 8, and Hour 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of hospital stay is measured in days and counted from day of admission to day of discharge. | Subjects will be followed for the duration of hospital stay until discharge |
| Duration of O2 Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Chen, M.D. | UCSF Benioff Children's Hospital Oakland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Research Center Oakland | Oakland | California | 94609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard dry oxygen therapy |
| FG001 | Treatment | Heated and humidified oxygen therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard dry oxygen therapy |
| BG001 | Treatment | Heated and humidified oxygen therapy |
| 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 in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Hour 1, Hour 4, Hour 8, and Hour 12 |
|
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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 | Control | Standard dry oxygen therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diana Chen | UCLA Mattel Children's Hospital | 3108255930 | dychen@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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Duration on supplemental O2 was measured in hours.
| Subjects will be followed for the duration of oxygen requirement until oxygen discontinued |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Mean RDAI | Respiratory Distress Assessment Instrument (RDAI) is a validated clinical assessment scale used to evaluate severity of respiratory illness in children with bronchiolitis. It is based on 2 variables, wheezing and retractions. Points are applied to each variable to give a score ranging from 0 to 17. Higher total score means subject is clinically more severe. | Mean | Standard Deviation | units on a scale |
|
| Mean RR | Mean | Standard Deviation | bpm |
|
| Mean sick days | Mean | Standard Deviation | days |
|
| Respiratory Syncytial Virus (RSV) positive | Count of Participants | Participants |
|
| Family history of asthma | Count of Participants | Participants |
|
| Smoke exposure at home | Count of Participants | Participants |
|
| Inhaled albuterol in emergency department | Count of Participants | Participants |
|
| Systemic steroids in emergency department | Count of Participants | Participants |
|
Heated and humidified oxygen therapy
|
|
| Primary | Change in Respiratory Rate (RR) From Baseline | Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module. | Posted | Mean | Standard Deviation | breaths per minute | Baseline, Hour 1, Hour 4, Hour 8, and Hour 12 |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay is measured in days and counted from day of admission to day of discharge. | Posted | Mean | Standard Deviation | days | Subjects will be followed for the duration of hospital stay until discharge |
|
|
|
| Secondary | Duration of O2 Use | Duration on supplemental O2 was measured in hours. | Posted | Mean | Standard Deviation | hours | Subjects will be followed for the duration of oxygen requirement until oxygen discontinued |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Treatment | Heated and humidified oxygen therapy | 0 | 16 | 0 | 16 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hour 4 |
|
| Hour 8 |
|
| Hour 12 |
|