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Clinical Trials/NCT00457080
NCT00457080CompletedNot Applicable

Application of Capnography Monitoring on the General Care Nursing Unit

Texas Health Resources2 sites in 1 country60 target enrollmentStarted: October 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Increase the detection of undiagnosed obstructive sleep apnea (OSA)

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • < 18 y/o
  • A diagnosis of obstructive sleep apnea.

Outcomes

Primary Outcomes

Increase the detection of undiagnosed obstructive sleep apnea (OSA)

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (2)

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