Capnography in the Post-Anesthesia Care Unit (PACU)

• Conditions: Obstructive Sleep Apnea; Respiratory Insufficiency; Bariatric Surgery Candidate
• Interventions: Device: end-tidal CO2 (ETCO2) monitoring

• Registration Number: NCT03076047
• Lead Sponsor: University of South Florida

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).

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-09
• Study Start: 2017-11-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-30
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
end tidal CO2 (ETCO2) monitoring	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.

Primary Outcome Measures

Name	Time	Method
end-tidal carbon dioxide (ETCO2)	2-3 hours	end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals

Secondary Outcome Measures

Name	Time	Method
oxygen saturation (SPO2)	2-3 hours	oxygen saturation (SPO2) values from pulse oximetry

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States