Clinical trial NCT03076047: Capnography in the Post-Anesthesia Care Unit (PACU)
Official title: Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Bariatric Surgery Candidate
Respiratory Insufficiency
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2017-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at high-risk of obstructive sleep apnea undergoing gastric bypass surgery

Brief summary: To understand if a progressive increase in end-tidal carbon dioxide (CO2) levels are heralding respiratory difficulties before desaturation measured from capnography in obstructive sleep apnea patients, with the use of nasal prongs, transcutaneous monitors, Capnostream, and Massimo technologies.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* 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:

* \<18 years of age
* Not at risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire

Primary outcomes:
measure: end-tidal carbon dioxide (ETCO2)
timeFrame: 2-3 hours
Secondary outcomes:
measure: oxygen saturation (SPO2)
timeFrame: 2-3 hours
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
References:
citation: 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.
citation: 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.