Using Capnography to Reduce Hypoxia During Pediatric Sedation

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463527
• Other study ID #: 0904005003
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: December 13, 2017
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Hypoxia

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Yale-New Haven Children's Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)