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

July 8, 2008 updated by: Texas Health Resources
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Presbyterian Hospital of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Increase the detection of undiagnosed obstructive sleep apnea (OSA)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Health Resources

Investigators

  • Principal Investigator: Rob W Hutchison, Texas Health Resources

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

July 9, 2008

Last Update Submitted That Met QC Criteria

July 8, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPNO-P806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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