Capnography in the Post-Anesthesia Care Unit (PACU)
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|ClinicalTrials.gov Identifier: NCT03076047|
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea Bariatric Surgery Candidate Respiratory Insufficiency||Procedure: end-tidal CO2 (ETCO2) monitoring with Smart CapnoLine Plus O2|
Background and Significance Carbon dioxide (CO2) levels can be monitored throughout the respiratory cycle via capnography. In this way, capnography allows healthcare professionals to follow a number of respiratory factors (i.e., depression, apnea, and hypercapnia) in real-time. Earlier detection of alterations to ventilation status will better enable providers to more accurately dose medications during procedures, especially in at-risk patient populations such as patients with obstructive sleep apnea (OSA) [1, 2].
In a recent study of bariatric patients, approximately 15% experience postoperative pulmonary complications. These patients could benefit significantly from capnography monitoring as this measure can very accurately estimate the prevalence of respiratory complications.
Through this study we seek to understand how end-tidal CO2 (ETCO2) levels of patients with obstructive sleep apnea vary when patients are in the post-anesthesia care unit (PACU). By collecting information on patient outcomes, we hope to better understand the value of this monitoring technique in an at-risk patient population. Though capnography in the PACU has not previously been demonstrated to improve patient safety or satisfaction, capnography has never been studied in a population of patients who are at risk of obstructive sleep apnea.
Study Design This is a prospective, blinded observational pilot study to monitor if changes in end-tidal CO2 levels provide incremental value over pulse oximetry when detecting respiratory difficulties (i.e., hypercapnia).
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)|
|Actual Study Start Date :||November 6, 2017|
|Actual Primary Completion Date :||February 9, 2018|
|Actual Study Completion Date :||February 9, 2018|
end tidal CO2 (ETCO2) monitoring
We will continuously record capnography data from the patients while they are in the post-anesthesia care unit (PACU). Study personnel will visit each patient while the patient is in the PACU to promote compliance with continuous CO2 monitoring.
Procedure: end-tidal CO2 (ETCO2) monitoring with Smart CapnoLine Plus O2
monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2
- end-tidal carbon dioxide (ETCO2) [ Time Frame: 2-3 hours ]end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals
- oxygen saturation (SPO2) [ Time Frame: 2-3 hours ]oxygen saturation (SPO2) values from pulse oximetry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076047
|United States, Florida|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|