NCT01463527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed
Last Updated

January 11, 2018

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

October 24, 2011

Results QC Date

January 14, 2014

Last Update Submit

December 13, 2017

Conditions

HypoventilationHypoxia

Keywords

Hypoventilation during sedationHypoxia associated with hypoventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (2)

Open Capnography

EXPERIMENTAL
Device: Nellcor NPB-70 Capnograph

Capnography Blind

PLACEBO COMPARATOR
Device: Nellcor NPB-70 Capnograph

Interventions

Nellcor NPB-70 CapnographDEVICE

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 BlindOpen Capnography

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Unable to tolerate nasal-oral cannula
  • Conditions that effect end-tidal carbon dioxide measurement (active asthma, diabetic ketoacidosis, severe dehydration or trauma)
  • Intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 25445871DERIVED

MeSH Terms

Conditions

HypoventilationHypoxia

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

No serious adverse events were recorded. Since these events are rare and this study was not powered to detect them, we are unable to predict how capnography may have impacted staff behavior and patient outcomes for these less frequent events.

Results Point of Contact

Title
Dr. Melissa Langhan
Organization
Yale University
melissa.langhan@yale.edu
203-737-7413

Study Officials

  • Melissa Langhan, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

November 2, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 11, 2018

Results First Posted

August 4, 2014

Record last verified: 2017-12

Locations

US(1)