Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2017-11-06
2023-02-09
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
end-tidal CO2 (ETCO2) monitoring
monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2, Capnostream, and Massimo
Interventions
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end-tidal CO2 (ETCO2) monitoring
monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2, Capnostream, and Massimo
Eligibility Criteria
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Inclusion Criteria
* Patients who have are at TGH for bariatric surgery
* BMI \> 30
* At risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire
Exclusion Criteria
* Not at risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
University of South Florida
OTHER
Responsible Party
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Enrico Camporesi
Principal Investigator
Locations
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Tampa General Hospital
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Mehta PP, Kochhar G, Albeldawi M, Kirsh B, Rizk M, Putka B, John B, Wang Y, Breslaw N, Lopez R, Vargo JJ. Capnographic Monitoring in Routine EGD and Colonoscopy With Moderate Sedation: A Prospective, Randomized, Controlled Trial. Am J Gastroenterol. 2016 Mar;111(3):395-404. doi: 10.1038/ajg.2015.437. Epub 2016 Feb 23.
Barnett S, Hung A, Tsao R, Sheehan J, Bukoye B, Sheth SG, Leffler DA. Capnographic Monitoring of Moderate Sedation During Low-Risk Screening Colonoscopy Does Not Improve Safety or Patient Satisfaction: A Prospective Cohort Study. Am J Gastroenterol. 2016 Mar;111(3):388-94. doi: 10.1038/ajg.2016.2. Epub 2016 Feb 2.
Other Identifiers
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Pro00027304
Identifier Type: -
Identifier Source: org_study_id
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