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Capnography in the Post-Anesthesia Care Unit (PACU)

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ClinicalTrials.gov Identifier: NCT03076047
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Enrico Camporesi, 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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Bariatric Surgery Candidate Respiratory Insufficiency Procedure: end-tidal CO2 (ETCO2) monitoring with Smart CapnoLine Plus O2

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).

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.
Procedure: end-tidal CO2 (ETCO2) monitoring with Smart CapnoLine Plus O2
monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2




Primary Outcome Measures :
  1. end-tidal carbon dioxide (ETCO2) [ Time Frame: 2-3 hours ]
    end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals


Secondary Outcome Measures :
  1. oxygen saturation (SPO2) [ Time Frame: 2-3 hours ]
    oxygen saturation (SPO2) values from pulse oximetry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at high-risk of obstructive sleep apnea undergoing gastric bypass surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076047


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Medtronic - MITG

Publications:
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Responsible Party: Enrico Camporesi, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT03076047    
Other Study ID Numbers: Pro00027304
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Anesthetics
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Central Nervous System Depressants
Physiological Effects of Drugs