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

This study has been completed.
Sponsor:
Information provided by:
Texas Health Resources
ClinicalTrials.gov Identifier:
NCT00457080
First received: April 3, 2007
Last updated: July 8, 2008
Last verified: July 2008
  Purpose

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 Intervention
Postoperative Complications
Device: Alaris ETCO2 monitor - cont. resp. rate, & apnea events

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Application of Capnography Monitoring on the General Care Nursing Unit

Resource links provided by NLM:


Further study details as provided by Texas Health Resources:

Primary Outcome Measures:
  • Increase the detection of undiagnosed obstructive sleep apnea (OSA)

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

Estimated Enrollment: 60
Study Start Date: October 2006
Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

ClinicalTrials.gov Identifier: NCT00457080     History of Changes
Other Study ID Numbers: CAPNO-P806
Study First Received: April 3, 2007
Last Updated: July 8, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014