Bronchiolitis, Hypoxemia
Conditions
Keywords
Heat, Humidification, Oxygen
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHeated and humidified oxygen
Sponsors
UCSF Benioff Children's Hospital Oakland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
* Ages ≤24 months of age * Physician diagnosed bronchiolitis * Admitted to pediatric floor * Supplemental oxygen requirement, \<4 L/min, for hypoxemia, oxygen saturation \<92% in room air
Exclusion criteria
* Prematurity, born \<37 weeks gestational age * Admitted to pediatric intensive care unit for medical indication * Requirement of heated, humidified high flow system * Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement) * Neuromuscular disorders * Chromosomal defects * Metabolic disorders * Immunodeficiency * Unrepaired cardiac abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Baseline, Hour 1, Hour 4, Hour 8, and Hour 12 | 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. |
| Change in Respiratory Rate (RR) From Baseline | Baseline, Hour 1, Hour 4, Hour 8, and Hour 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Subjects will be followed for the duration of hospital stay until discharge | Length of hospital stay is measured in days and counted from day of admission to day of discharge. |
| Duration of O2 Use | Subjects will be followed for the duration of oxygen requirement until oxygen discontinued | Duration on supplemental O2 was measured in hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Standard dry oxygen therapy | 16 |
| Treatment Heated and humidified oxygen therapy | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Treatment | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 32 Participants | 16 Participants | 16 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Family history of asthma | 14 Participants | 8 Participants | 6 Participants |
| Inhaled albuterol in emergency department | 19 Participants | 9 Participants | 10 Participants |
| Mean RDAI | 4.90 units on a scale STANDARD_DEVIATION 3.16 | 4.44 units on a scale STANDARD_DEVIATION 2.61 | 5.38 units on a scale STANDARD_DEVIATION 3.65 |
| Mean RR | 46.8 bpm STANDARD_DEVIATION 11.9 | 48.19 bpm STANDARD_DEVIATION 11.3 | 45.44 bpm STANDARD_DEVIATION 12.74 |
| Mean sick days | 4.41 days STANDARD_DEVIATION 1.39 | 4.25 days STANDARD_DEVIATION 1.43 | 4.56 days STANDARD_DEVIATION 1.36 |
| Race/Ethnicity, Customized Ethnicity Black | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 12 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 9 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity White | 6 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United States | 32 Participants | 16 Participants | 16 Participants |
| Respiratory Syncytial Virus (RSV) positive | 24 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Female | 12 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 20 Participants | 11 Participants | 9 Participants |
| Smoke exposure at home | 9 Participants | 3 Participants | 6 Participants |
| Systemic steroids in emergency department | 11 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 1 | 4.69 units on a scale | Standard Deviation 3.4 |
| Control | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 4 | 4.27 units on a scale | Standard Deviation 3.01 |
| Control | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 8 | 4.33 units on a scale | Standard Deviation 3.34 |
| Control | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 12 | 3.64 units on a scale | Standard Deviation 2.25 |
| Treatment | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 12 | 3.2 units on a scale | Standard Deviation 2.37 |
| Treatment | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 1 | 2.69 units on a scale | Standard Deviation 3.2 |
| Treatment | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 8 | 3.44 units on a scale | Standard Deviation 3.2 |
| Treatment | Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. | Hour 4 | 3 units on a scale | Standard Deviation 2.63 |
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.
Time frame: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Respiratory Rate (RR) From Baseline | Hour 1 | 44.81 breaths per minute | Standard Deviation 12.69 |
| Control | Change in Respiratory Rate (RR) From Baseline | Hour 8 | 43.75 breaths per minute | Standard Deviation 8.06 |
| Control | Change in Respiratory Rate (RR) From Baseline | Hour 4 | 45.73 breaths per minute | Standard Deviation 14.26 |
| Control | Change in Respiratory Rate (RR) From Baseline | Hour 12 | 43.36 breaths per minute | Standard Deviation 8.54 |
| Control | Change in Respiratory Rate (RR) From Baseline | Baseline | 45.44 breaths per minute | Standard Deviation 12.74 |
| Treatment | Change in Respiratory Rate (RR) From Baseline | Hour 12 | 44.93 breaths per minute | Standard Deviation 9.92 |
| Treatment | Change in Respiratory Rate (RR) From Baseline | Baseline | 48.19 breaths per minute | Standard Deviation 11.3 |
| Treatment | Change in Respiratory Rate (RR) From Baseline | Hour 1 | 45.81 breaths per minute | Standard Deviation 12.16 |
| Treatment | Change in Respiratory Rate (RR) From Baseline | Hour 4 | 47.25 breaths per minute | Standard Deviation 8.84 |
| Treatment | Change in Respiratory Rate (RR) From Baseline | Hour 8 | 43.44 breaths per minute | Standard Deviation 8.74 |
Secondary
Duration of O2 Use
Duration on supplemental O2 was measured in hours.
Time frame: Subjects will be followed for the duration of oxygen requirement until oxygen discontinued
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Duration of O2 Use | 60.02 hours | Standard Deviation 48.93 |
| Treatment | Duration of O2 Use | 72.11 hours | Standard Deviation 75.38 |
Secondary
Length of Hospital Stay
Length of hospital stay is measured in days and counted from day of admission to day of discharge.
Time frame: Subjects will be followed for the duration of hospital stay until discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Length of Hospital Stay | 4.44 days | Standard Deviation 2.31 |
| Treatment | Length of Hospital Stay | 4.56 days | Standard Deviation 4.1 |