NCT00457080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

July 9, 2008

Status Verified

July 1, 2008

First QC Date

April 3, 2007

Last Update Submit

July 8, 2008

Conditions

Keywords

capnographysafetyopioidsrespiratory depressionpostoperativeorthopedicOSAapnea

Outcome Measures

Primary Outcomes (1)

  • Increase the detection of undiagnosed obstructive sleep apnea (OSA)

Secondary Outcomes (1)

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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

Related Publications (13)

  • 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.

    PMID: 17319481BACKGROUND
  • 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.

    PMID: 17252891BACKGROUND
  • 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.

    PMID: 17222941BACKGROUND
  • 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.

    PMID: 17141136BACKGROUND
  • 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.

    PMID: 16702250BACKGROUND
  • 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.

    PMID: 16580478BACKGROUND
  • 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.

    PMID: 16187465BACKGROUND
  • 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.

    PMID: 16117730BACKGROUND
  • 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.

    PMID: 15845739BACKGROUND
  • Hatlestad D. Capnography in sedation and pain management. Emerg Med Serv. 2005 Mar;34(3):65-9.

    PMID: 15839539BACKGROUND
  • 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.

    PMID: 15832109BACKGROUND
  • 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.

    PMID: 15829165BACKGROUND
  • 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.

    PMID: 15705999BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsRespiratory InsufficiencyApnea

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Rob W Hutchison

    Texas Health Resources

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

October 1, 2006

Study Completion

February 1, 2007

Last Updated

July 9, 2008

Record last verified: 2008-07

Locations