Capnography in the Post-Anesthesia Care Unit (PACU)

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076047
• Other study ID #: Pro00027304
• Status: Recruiting
• Start date: November 6, 2017
• Est. completion date: February 9, 2023

Study information

• Verified date: June 2022
• Source: University of South Florida
• Contact: Enrico Camporesi, MD
• Phone: 813-844-4434
• Email: ecampore[@]health.usf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obstructive Sleep Apnea
• Respiratory Insufficiency
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Medtronic - MITG

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	end-tidal carbon dioxide (ETCO2)	end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals	2-3 hours
Secondary	oxygen saturation (SPO2)	oxygen saturation (SPO2) values from pulse oximetry	2-3 hours