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Using Capnography to Reduce Hypoxia During Pediatric Sedation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463527
First Posted: November 2, 2011
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
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.

Condition Intervention
Hypoventilation Hypoxia Device: Nellcor NPB-70 Capnograph

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Using Capnography to Reduce the Incidence of Hypoxia in Children During Moderate Sedation in the Pediatric Emergency Department: A Randomized Controlled Trial

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Frequency of Staff Interventions for Hypoventilation. [ Time Frame: 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:
  • Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%. [ Time Frame: Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes) ]

Enrollment: 167
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Capnography 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
Placebo Comparator: Capnography Blind 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463527


Locations
United States, Connecticut
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Melissa Langhan, MD Yale University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01463527     History of Changes
Other Study ID Numbers: 0904005003
First Submitted: October 24, 2011
First Posted: November 2, 2011
Results First Submitted: January 14, 2014
Results First Posted: August 4, 2014
Last Update Posted: November 16, 2017
Last Verified: July 2014

Keywords provided by Yale University:
Hypoventilation during sedation
Hypoxia associated with hypoventilation

Additional relevant MeSH terms:
Hypoxia
Hypoventilation
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases