Hypoxia, Respiratory Distress
Conditions
Keywords
Hypoxia, Respiratory Distress
Brief summary
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia.
Detailed description
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress will be evaluated for use of the modified bCPAP device as treatment for their respiratory distress (in addition to their routine care, i.e. antibiotics, nutrition support)
Interventions
DEVICEBubble CPAP
Respiratory assistance
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation \<92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score \>3
Exclusion criteria
* Pneumothorax * Congenital lung disease * Cyanotic heart disease * Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable * Nasal tissue injury * Active nosebleed * Recent abdominal surgery or significant abdominal distension * Agonal respirations * GCS \<3 * Imminent death within the next 1-2hou
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period | 28 days | A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| show decreased mortality in patients treated with a modified bCPAP respiratory support device. | 28 days | Comparison of historic mortality data for children admitted with respiratory distress to mortality rate seen during the study. Respiratory distress scores using the TAL score (18) will be recorded prior to therapy and throughout the hospital course |
Countries
Uganda
Outcome results
None listed