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Completed

NCT Number: NCT00457080

Application of Capnography Monitoring on the General Care Nursing Unit

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.

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Key information

Conditions

Postoperative Complications Apnea Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Sponsors and collaborators

Lead sponsor

Texas Health Resources

Other

Registry information

Acronym: ETCO2

Important dates

Study start
2006
Study completion
2007
First posted
Apr 5, 2007
Registry last updated
Jul 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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