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Using Capnography to Reduce Hypoxia During Pediatric Sedation

Primary Purpose

Hypoventilation, Hypoxia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nellcor NPB-70 Capnograph

About this trial

This is an interventional prevention trial for Hypoventilation focused on measuring Hypoventilation during sedation, Hypoxia associated with hypoventilation

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale-New Haven Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Open Capnography

Capnography Blind

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01463527

First Posted

October 24, 2011

Last Updated

December 13, 2017

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT01463527

Brief Title

Using Capnography to Reduce Hypoxia During Pediatric Sedation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoventilation, Hypoxia

Keywords

Hypoventilation during sedation, Hypoxia associated with hypoventilation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Capnography

Arm Type

Experimental

Arm Title

Capnography Blind

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Nellcor NPB-70 Capnograph

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of Staff Interventions for Hypoventilation.

Description

These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.

Time Frame

Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)

Secondary Outcome Measure Information:

Title

Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.

Description

Time Frame

Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa Langhan, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale-New Haven Children's Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25445871

Citation

Langhan ML, Shabanova V, Li FY, Bernstein SL, Shapiro ED. A randomized controlled trial of capnography during sedation in a pediatric emergency setting. Am J Emerg Med. 2015 Jan;33(1):25-30. doi: 10.1016/j.ajem.2014.09.050. Epub 2014 Oct 5.

Results Reference

derived

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Using Capnography to Reduce Hypoxia During Pediatric Sedation

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