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Application of Capnography Monitoring on the General Care Nursing Unit (ETCO2)

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ClinicalTrials.gov Identifier: NCT00457080
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : July 9, 2008
Sponsor:
Information provided by:
Texas Health Resources

Study Description
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Brief Summary:
The aim of this study is to increase the detection of undiagnosed obstructive sleep apnea (OSA) and secondly to increase the sensitivity for detection of respiratory depression (< 6 breaths per minute) in post operative patients on the general care nursing unit.

Condition or disease Intervention/treatment Phase
Postoperative Complications Device: Alaris ETCO2 monitor - cont. resp. rate, & apnea events Not Applicable

Detailed Description:

Measures: This is an IRB approved prospective trial beginning with randomization in the post anesthesia care unit (PACU) and continuing for thirty six hours post orthopedic surgical procedure. The patients are randomized into a capnography or standard of care group and the percentage of newly identified OSA patients were measured in each group using the criteria set forth by 2006 American Society of Anesthesiologist practice guideline (Anesthesiology 2006; 104:1081-93).

Background/Changes: Hospital complications are three times higher in patients with obstructive sleep apnea and the majority of these complications are related to opioid induced respiratory depression (Mayo Clin Proc Sept 2001:897-905). American Society of Anesthesiologist 2006 practice guideline for perioperative management of patients with obstructive sleep apnea (Anesthesiology 2006; 104:1081-93) lists the criteria for identifying undiagnosed obstructive sleep apnea. One of the risk factors in the guideline lists apnea (pauses in breathing). Capnography measures apnea episodes and continuously monitors respiration rate.

As previously described, five percent of the general population has obstructive sleep apnea (OSA) and the prevalence among patients requiring surgery is 9% (NEJM 1993; 328:1230-1235). Between 50-80% of OSA individuals are undiagnosed when presenting for surgery.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of Capnography Monitoring on the General Care Nursing Unit
Study Start Date : October 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Increase the detection of undiagnosed obstructive sleep apnea (OSA)

Secondary Outcome Measures :
  1. Increase the sensitivity for detection of respiratory depression (< 6 breaths per minute) in post operative patients on the general care nursing unit

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Orthopedic surgical procedure
  • Respiration rate < 10 breaths per minute requiring supplement oxygen

  • One of the following:

    • body mass index >30
    • history of snoring
    • basal rate of opioid, and
    • one event of RR <10 in the post anesthesia care unit.

Exclusion Criteria:

  • COPD
  • < 18 y/o
  • A diagnosis of obstructive sleep apnea.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00457080


Locations
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Texas Health Resources
Investigators
Principal Investigator: Rob W Hutchison Texas Health Resources
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00457080     History of Changes
Other Study ID Numbers: CAPNO-P806
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

Keywords provided by Texas Health Resources:
capnography
safety
opioids
respiratory depression
 postoperative
orthopedic
OSA
apnea

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes