Capnography in the Post-Anesthesia Care Unit (PACU)

NCT ID: NCT03076047

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-06

Study Completion Date

2023-02-09

Brief Summary

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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

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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

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Obstructive Sleep Apnea Bariatric Surgery Candidate Respiratory Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

end-tidal CO2 (ETCO2) monitoring

Intervention Type DEVICE

monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2, Capnostream, and Massimo

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Enrico Camporesi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Enrico Camporesi, MD

Role: CONTACT

813-844-4434

Facility Contacts

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Enrico M. Camporesi, MD

Role: primary

813-844-4434

References

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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.

Reference Type BACKGROUND
PMID: 26902229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26832654 (View on PubMed)

Other Identifiers

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Pro00027304

Identifier Type: -

Identifier Source: org_study_id

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