Using Capnography to Reduce Hypoxia During Pediatric Sedation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

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.

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RECRUITING PHASE3

Detailed Description

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Conditions

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Hypoventilation Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Open Capnography

Group Type EXPERIMENTAL

Nellcor NPB-70 Capnograph

Intervention Type DEVICE

Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings

Capnography Blind

Group Type PLACEBO_COMPARATOR

Nellcor NPB-70 Capnograph

Intervention Type DEVICE

Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings

Interventions

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Nellcor NPB-70 Capnograph

Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings

Intervention Type DEVICE

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No