Application of Capnography Monitoring on the General Care Nursing Unit

NCT ID: NCT00457080

Last Updated: 2008-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Postoperative Complications

Keywords

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capnography safety opioids respiratory depression postoperative orthopedic OSA apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Alaris ETCO2 monitor - cont. resp. rate, & apnea events

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Health Resources

OTHER

Sponsor Role lead

Principal Investigators

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Rob W Hutchison

Role: PRINCIPAL_INVESTIGATOR

Texas Health Resources

Locations

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Presbyterian Hospital of Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17319481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17252891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17222941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17141136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16702250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16580478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16187465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16117730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15845739 (View on PubMed)

Hatlestad D. Capnography in sedation and pain management. Emerg Med Serv. 2005 Mar;34(3):65-9.

Reference Type BACKGROUND
PMID: 15839539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15832109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15829165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15705999 (View on PubMed)

Other Identifiers

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CAPNO-P806

Identifier Type: -

Identifier Source: org_study_id