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

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alaris ETCO2 monitor - cont. resp. rate, & apnea events
Sponsored by
Texas Health Resources
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Complications focused on measuring capnography, safety, opioids, respiratory depression, postoperative, orthopedic, OSA, apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Presbyterian Hospital of Dallas

Outcomes

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

Full Information

First Posted
April 3, 2007
Last Updated
July 8, 2008
Sponsor
Texas Health Resources
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1. Study Identification

Unique Protocol Identification Number
NCT00457080
Brief Title
Application of Capnography Monitoring on the General Care Nursing Unit
Acronym
ETCO2
Official Title
Application of Capnography Monitoring on the General Care Nursing Unit
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Texas Health Resources

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
capnography, safety, opioids, respiratory depression, postoperative, orthopedic, OSA, apnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Alaris ETCO2 monitor - cont. resp. rate, & apnea events
Primary Outcome Measure Information:
Title
Increase the detection of undiagnosed obstructive sleep apnea (OSA)
Secondary Outcome Measure Information:
Title
Increase the sensitivity for detection of respiratory depression (< 6 breaths per minute) in post operative patients on the general care nursing unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob W Hutchison
Organizational Affiliation
Texas Health Resources
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17319481
Citation
Hutchison R. Capnography monitoring during opioid PCA administration. J Opioid Manag. 2006 Jul-Aug;2(4):207-8. doi: 10.5055/jom.2006.0032. No abstract available.
Results Reference
background
PubMed Identifier
17252891
Citation
Kirk VG, Batuyong ED, Bohn SG. Transcutaneous carbon dioxide monitoring and capnography during pediatric polysomnography. Sleep. 2006 Dec;29(12):1601-8. doi: 10.1093/sleep/29.12.1601.
Results Reference
background
PubMed Identifier
17222941
Citation
Krauss B, Hess DR. Capnography for procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2007 Aug;50(2):172-81. doi: 10.1016/j.annemergmed.2006.10.016. Epub 2007 Jan 12.
Results Reference
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PubMed Identifier
17141136
Citation
Anderson JL, Junkins E, Pribble C, Guenther E. Capnography and depth of sedation during propofol sedation in children. Ann Emerg Med. 2007 Jan;49(1):9-13. doi: 10.1016/j.annemergmed.2006.06.011. Epub 2006 Aug 17.
Results Reference
background
PubMed Identifier
16702250
Citation
Lightdale JR, Goldmann DA, Feldman HA, Newburg AR, DiNardo JA, Fox VL. Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial. Pediatrics. 2006 Jun;117(6):e1170-8. doi: 10.1542/peds.2005-1709. Epub 2006 May 15.
Results Reference
background
PubMed Identifier
16580478
Citation
Anderson MR. Capnography: considerations for its use in the emergency department. J Emerg Nurs. 2006 Apr;32(2):149-53. doi: 10.1016/j.jen.2005.12.025. No abstract available.
Results Reference
background
PubMed Identifier
16187465
Citation
Corbo J, Bijur P, Lahn M, Gallagher EJ. Concordance between capnography and arterial blood gas measurements of carbon dioxide in acute asthma. Ann Emerg Med. 2005 Oct;46(4):323-7. doi: 10.1016/j.annemergmed.2004.12.005.
Results Reference
background
PubMed Identifier
16117730
Citation
Verschuren F, Heinonen E, Clause D, Zech F, Reynaert MS, Liistro G. Volumetric capnography: reliability and reproducibility in spontaneously breathing patients. Clin Physiol Funct Imaging. 2005 Sep;25(5):275-80. doi: 10.1111/j.1475-097X.2005.00620.x.
Results Reference
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PubMed Identifier
15845739
Citation
Fisher QA. Can capnography substitute for auscultation in sedation cases? Anesth Analg. 2005 May;100(5):1546. doi: 10.1213/01.ANE.0000151470.50760.4A. No abstract available.
Results Reference
background
PubMed Identifier
15839539
Citation
Hatlestad D. Capnography in sedation and pain management. Emerg Med Serv. 2005 Mar;34(3):65-9.
Results Reference
background
PubMed Identifier
15832109
Citation
Eisenbacher S, Heard L. Capnography in the gastroenterology lab. Gastroenterol Nurs. 2005 Mar-Apr;28(2):99-105; quiz 105-6. doi: 10.1097/00001610-200503000-00003.
Results Reference
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PubMed Identifier
15829165
Citation
Dziewas R, Hopmann B, Humpert M, Bontert M, Dittrich R, Ludemann P, Young P, Ringelstein EB, Nabavi DG. Capnography screening for sleep apnea in patients with acute stroke. Neurol Res. 2005 Jan;27(1):83-7. doi: 10.1179/016164105X18359.
Results Reference
background
PubMed Identifier
15705999
Citation
Engoren M, Plewa M, O'Hara D, Kline JA. Evaluation of capnography using a genetic algorithm to predict PaCO2. Chest. 2005 Feb;127(2):579-84. doi: 10.1378/chest.127.2.579.
Results Reference
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Application of Capnography Monitoring on the General Care Nursing Unit

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