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)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency; Obstructive Sleep Apnea; Bariatric Surgery Candidate
• Intervention / Treatment: Device: end-tidal CO2 (ETCO2) monitoring

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Enrico Camporesi, MD; Phone Number: 813-844-4434; Email: ecampore@health.usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Enrico M. Camporesi, MD; Phone Number: 813-844-4434; Email: ecampore@health.usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients at high-risk of obstructive sleep apnea undergoing gastric bypass surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
end-tidal carbon dioxide (ETCO2)	end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals	2-3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen saturation (SPO2)	oxygen saturation (SPO2) values from pulse oximetry	2-3 hours

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Medtronic - MITG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Anticipated): February 9, 2023
• Study Completion (Anticipated): February 9, 2023

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: Pro00027304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes