Using Capnography to Reduce Hypoxia During Pediatric Sedation

Study Overview
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Brief Summary
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The investigators hypothesize that the addition of capnography during moderate sedation will improve recognition of hypoventilation and apnea. This will lead to an increased frequency of staff interventions such as verbal or physical stimulation for these events in order to improve ventilation which will in turn lead to a reduction in the frequency of oxygen desaturations. If capnography proves to be effective in creating earlier detection and intervention for hypoventilation and apnea during moderate sedation provided by non-anesthesiologists, this device can be used in a variety of clinical settings to enhance patient safety.

Official Title
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Using Capnography to Reduce the Incidence of Hypoxia in Children During Moderate Sedation in the Pediatric Emergency Department: A Randomized Controlled Trial

Conditions
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Hypoxia, Hypoventilation

Intervention / Treatment
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* Device: Nellcor NPB-70 Capnograph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 1-20 years old who require IV sedation in the Pediatric Emergency Department at Yale-New Haven Children's Hospital Exclusion Criteria: Unable to tolerate nasal-oral cannula Conditions that effect end-tidal carbon dioxide measurement (active asthma, diabetic ketoacidosis, severe dehydration or trauma) Intubation

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Capnography<br> | Device: Nellcor NPB-70 Capnograph<br>* Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings<br>|
| Placebo Comparator: Capnography Blind<br> | Device: Nellcor NPB-70 Capnograph<br>* Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Staff Interventions for Hypoventilation. | These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices. | Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%. | While there were 77 patients per group, each patient had vital signs measured every 30 seconds for the duration of their stay. This resulted in a variable amount of time points (data points) recorded per patient. Our event frequency was the number of events (outcome measure of abnormal vital signs) per number of time points for each patient. This is presented as an event rate. | Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoventilation during sedation, Hypoxia associated with hypoventilation