Obstructive Sleep ApneaNCT03076047
Capnography in the Post-Anesthesia Care Unit (PACU)
An observational study of Obstructive Sleep Apnea and Bariatric Surgery Candidate, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Bariatric Surgery Candidate, Respiratory Insufficiency
- What is being tested?
- end-tidal CO2 (ETCO2) monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 9 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at high-risk of obstructive sleep apnea undergoing gastric bypass surgery
Who may be able to join
- > 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
Who cannot join
- <18 years of age
- Not at risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Enrico M. Camporesi, MD, 813-844-4434, ecampore@health.usf.edu
About this study
Official title: Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)
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.
Read the 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).
- Being tested
- end-tidal CO2 (ETCO2) monitoring
- Medical subject headings
- Sleep Apnea, Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
end-tidal CO2 (ETCO2) monitoringDevice
monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2, Capnostream, and Massimo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: end-tidal CO2 (ETCO2) monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
end-tidal carbon dioxide (ETCO2)
end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals
Measured: 2-3 hours
Secondary outcomes (1)
oxygen saturation (SPO2)
oxygen saturation (SPO2) values from pulse oximetry
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start6 Nov 2017
- Primary completion9 Feb 2023 (estimated)
- Study completion9 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Enrico Camporesi, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076047
- Sponsor's protocol ID
- Pro00027304
- Status last verified
- Jun 2022
- First submitted
- 6 Mar 2017
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26902229Barnett 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.
PubMed 26832654
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)
- ClinicalTrials.gov ID
- NCT03076047
- Acronym / sponsor ID
- Pro00027304
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 9 Feb 2023 (estimated)
- Study completion
- 9 Feb 2023 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| end tidal CO2 (ETCO2) monitoring | – | Device: end-tidal CO2 (ETCO2) monitoringWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at high-risk of obstructive sleep apnea undergoing gastric bypass surgery
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (2 listed)
- <18 years of age
- Not at risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| end-tidal CO2 (ETCO2) monitoringmonitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2, Capnostream, and Massimo | Device | end tidal CO2 (ETCO2) monitoring |
Primary outcome
end-tidal carbon dioxide (ETCO2)
Time frame: 2-3 hours
end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals
1 secondary outcome
oxygen saturation (SPO2)
Time frame: 2-3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 26902229Mehta 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.
- Background: PubMed 26832654Barnett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Bariatric Surgery Candidate, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Camporesi, MD (813-844-4434, ecampore@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end-tidal carbon dioxide (ETCO2) (time frame: 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.