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Capnography in the Post-Anesthesia Care Unit (PACU)

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University of South Florida

Status

Enrolling

Conditions

Respiratory Insufficiency
Bariatric Surgery Candidate
Obstructive Sleep Apnea

Treatments

Device: end-tidal CO2 (ETCO2) monitoring

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03076047
Pro00027304

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

end tidal CO2 (ETCO2) monitoring
Description:
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.
Treatment:
Device: end-tidal CO2 (ETCO2) monitoring

Trial contacts and locations

1

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Central trial contact

Enrico Camporesi, MD

Data sourced from clinicaltrials.gov

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