N/A N=167 Randomized Single-blind Prevention

Using Capnography to Reduce Hypoxia During Pediatric Sedation

Hypoventilation · Hypoxia

Bottom Line

View on ClinicalTrials.gov: NCT01463527 ↗

Enrolled (actual)

167

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Frequency of Staff Interventions for Hypoventilation. — 0.39; 0.396 Events per patient minute of sedation

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nellcor NPB-70 Capnograph (Device)
Age: Pediatric, Adult · 1+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Staff Interventions for Hypoventilation.	0.39; 0.396	—
SECONDARY Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.	0.024; 0.016	0.30

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01463527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.