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Postoperative ComplicationsETCO2NCT00457080

Application of Capnography Monitoring on the General Care Nursing Unit

A study testing Alaris ETCO2 monitor - cont. resp. rate, & apnea events in people with Postoperative Complications, run by Texas Health Resources at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Complications
What is being tested?
Alaris ETCO2 monitor - cont. resp. rate, & apnea events
Type of treatment
Medical device
How many people
60 participants
Where
1 siteUnited States
Study dates
Oct 2006to Feb 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

Other trials in United States

About this study

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.

Read the 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.

Being tested
Alaris ETCO2 monitor - cont. resp. rate, & apnea events
Keywords
capnography, safety, opioids, respiratory depression, postoperative, orthopedic, OSA, apnea
Medical subject headings
Postoperative Complications, Respiratory Insufficiency, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alaris ETCO2 monitor - cont. resp. rate, & apnea eventsDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase the detection of undiagnosed obstructive sleep apnea (OSA)

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2007 (estimated)
  2. Study startOct 2006
  3. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00457080
Sponsor's protocol ID
CAPNO-P806
Acronym
ETCO2
Status last verified
Jul 2008
First submitted
3 Apr 2007
Last updated
9 Jul 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17319481

  • 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.

    PubMed 17252891

  • 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.

    PubMed 17222941

  • 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.

    PubMed 17141136

  • 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.

    PubMed 16702250

  • 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.

    PubMed 16580478

  • 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.

    PubMed 16187465

  • 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.

    PubMed 16117730

  • 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.

    PubMed 15845739

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

    PubMed 15839539

  • 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.

    PubMed 15832109

  • 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.

    PubMed 15829165

  • 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.

    PubMed 15705999

Questions about this trial

What is this clinical trial studying?

A study testing Alaris ETCO2 monitor - cont. resp. rate, & apnea events in people with Postoperative Complications, run by Texas Health Resources at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase the detection of undiagnosed obstructive sleep apnea (OSA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00457080, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2008.

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