Application of Capnography Monitoring on the General Care Nursing Unit

Postoperative Complications Clinical Trial

— ETCO2  

Official title:

Application of Capnography Monitoring on the General Care Nursing Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457080
• Other study ID #: CAPNO-P806
• Status: Completed
• Phase: N/A
• First received: April 3, 2007
• Last updated: July 8, 2008
• Start date: October 2006
• Est. completion date: February 2007

Study information

• Verified date: July 2008
• Source: Texas Health Resources
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
United States	Presbyterian Hospital of Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Health Resources

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Epub 2006 Aug 17. — View Citation

Anderson MR. Capnography: considerations for its use in the emergency department. J Emerg Nurs. 2006 Apr;32(2):149-53. — View 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. — View Citation

Dziewas R, Hopmann B, Humpert M, Böntert M, Dittrich R, Lüdemann 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. — View Citation

Eisenbacher S, Heard L. Capnography in the gastroenterology lab. Gastroenterol Nurs. 2005 Mar-Apr;28(2):99-105; quiz 105-6. Review. — View 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. — View Citation

Fisher QA. Can capnography substitute for auscultation in sedation cases? Anesth Analg. 2005 May;100(5):1546. — View Citation

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

Hutchison R. Capnography monitoring during opioid PCA administration. J Opioid Manag. 2006 Jul-Aug;2(4):207-8. — View Citation

Kirk VG, Batuyong ED, Bohn SG. Transcutaneous carbon dioxide monitoring and capnography during pediatric polysomnography. Sleep. 2006 Dec;29(12):1601-8. — View Citation

Krauss B, Hess DR. Capnography for procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2007 Aug;50(2):172-81. Epub 2007 Jan 12. — View 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. Epub 2006 May 15. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase the detection of undiagnosed obstructive sleep apnea (OSA)
Secondary	Increase the sensitivity for detection of respiratory depression (< 6 breaths per minute) in post operative patients on the general care nursing unit