Using Capnography to Reduce Hypoxia During Pediatric Sedation

Not Applicable

Completed

• Conditions: Hypoventilation; Hypoxia
• Interventions: Device: Nellcor NPB-70 Capnograph

• Registration Number: NCT01463527
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-01-14
• Results First Submitted QC: 2014-07-08
• Results First Posted: 2014-08-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Children 1-20 years old who require IV sedation in the Pediatric Emergency Department at Yale-New Haven Children's Hospital

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Capnography	Nellcor NPB-70 Capnograph	-
Capnography Blind	Nellcor NPB-70 Capnograph	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.	Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)	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.

Trial Locations

Locations (1)

Yale-New Haven Children's Hospital; 🇺🇸 New Haven, Connecticut, United States