Viewing Study NCT00457080



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Study NCT ID: NCT00457080
Status: COMPLETED
Last Update Posted: 2008-07-09
First Post: 2007-04-03

Brief Title: Application of Capnography Monitoring on the General Care Nursing Unit
Sponsor: Texas Health Resources
Organization: Texas Health Resources

Study Overview

Official Title: Application of Capnography Monitoring on the General Care Nursing Unit
Status: COMPLETED
Status Verified Date: 2008-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ETCO2
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
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 1041081-93

BackgroundChanges 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 2001897-905 American Society of Anesthesiologist 2006 practice guideline for perioperative management of patients with obstructive sleep apnea Anesthesiology 2006 1041081-93 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 3281230-1235 Between 50-80 of OSA individuals are undiagnosed when presenting for surgery

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None