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Using Capnography to Reduce Hypoxia During Pediatric Sedation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melissa Langhan, Yale University
ClinicalTrials.gov Identifier:
NCT01463527
First received: October 24, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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 Phase
Hypoventilation
Hypoxia
Device: Nellcor NPB-70 Capnograph
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Melissa Langhan, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01463527     History of Changes
Other Study ID Numbers: 0904005003
Study First Received: October 24, 2011
Results First Received: January 14, 2014
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014