NCT03076047

Capnography in the Post-Anesthesia Care Unit (PACU)

Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obstructive Sleep Apnea
• Bariatric Surgery Candidate
• Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2017-11-06
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2017-03-09
• Last updated: 2022-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study