Recruiting

Capnography

Sponsor:

University of South Florida

Code:

NCT03076047

Conditions

Obstructive Sleep Apnea

Bariatric Surgery Candidate

Respiratory Insufficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

end-tidal CO2 (ETCO2) monitoring

Study Details

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, with the use of nasal prongs, transcutaneous monitors, Capnostream, and Massimo technologies.

Conditions

Obstructive Sleep Apnea

Bariatric Surgery Candidate

Respiratory Insufficiency

Study ID

NCT03076047

Start date

Nov 6, 2017

Status verified date

Jun, 2022

Completion date

Feb 9, 2023

Anticipated

Primary completion date

Feb 9, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • end-tidal carbon dioxide (ETCO2) [ Time Frame: 2-3 hours ]

Central Contacts and Locations

Central contacts

Enrico Camporesi, MD

813-844-4434ecampore@health.usf.edu

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Enrico M. Camporesi, MD

813-844-4434ecampore@health.usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Jun 30, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2022-06-30.