Bariatric PatientsNCT01248312
Incidence of Hypercapnea in Morbidly Obese Post-Surgical Bariatric Patients Using the Sen Tec Transcutaneous PCO2 Monitor
An observational study of Bariatric Patients, run by Corewell Health East at 1 site in United States.
Trial summary
Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon dioxide is a gaseous product of the body's metabolism and is normally expelled through the lungs (breathed out). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Patients
- What is being tested?
- Sentec monitoring device and sentec monitor
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 morbidly obese post surgical laparoscopic bariatric patients and 10 thin subjects undergoing laparoscopic procedures
Who may be able to join
- Consenting male or female adults aged 18-65, scheduled to undergo elective laparoscopic gastric bypass (morbidly obese) or patients scheduled to undergo an abdominal procedure (thin) which will similarly require an overnight admission to Beaumont/Royal Oak Hospital
- Women must be nonpregnant and nonlactating, postmenopausal or surgically sterile. Women of childbearing age must have a negative pregnancy test (performed per standard hospital protocol
Who cannot join
- History of COPD (lung/breathing disease)
- Home O2 (oxygen) dependence (home CPAP use is acceptable)
- Pregnancy/nursing
- Scheduled to receive epidural pain management.(Epidural pain management is the continuous infusion of medication(s) into the space surrounding the spinal cord called the epidural space.)
- Participation in another clinical trial within the past 30days
- Skin condition that would interfere with the application of the forehead sensor
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Estimation of the Incidence of Hypercapnea in Morbidly Obese Post-Surgical Patients Using the Sen Tec Transcutaneous PCO2 Monitor
Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon dioxide is a gaseous product of the body's metabolism and is normally expelled through the lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the ventilation is inadequate to perform needed gas exchange; therefore resulting in decreased levels of oxygen and increased levels of carbon dioxide in the blood. It can cause an increased concentration of carbon dioxide and respiratory acidosis. Obesity is a multi-system disorder, particularly involving the respiratory (lungs/breathing) and cardiovascular (heart/vessel) systems. Obesity increases the risks for surgical and anesthetic complications before, during and following surgery.
Bariatric (weight loss) surgery is becoming a common procedure among the morbidly obese (100 lbs or more above normal weight), with recent studies highlighting the long-term health implications of surgical weight reduction, to include a decreased risk of hypertension (high blood pressure) and diabetes (increased sugar in blood). Obese patients are at increased risk of sleep apnea (stop breathing while asleep) and hypoventilation even without surgery, and these risks increase following administration of medications typically given during and after major surgical procedures. Hypoventilation can lead to hypercapnea, sedation (sleepiness), and acidosis (blood imbalance), resulting in further respiratory compromise (breathing problems) and cardiac morbidity (heart problems) as well as the risks inherent in re-intubating (needing to have a breathing tube place down into the lungs) the obese.Monitoring for hypoventilation can be difficult. Quantitative capnography (measuring carbon dioxide) is only appropriate for intubated patients (on a ventilator - breathing tube), and pulse oximetry (clip on finger that measures oxygen levels) does not adequately detect hypoventilation in patients receiving supplemental (additional) oxygen. Serial arterial blood gas (blood taken from an artery to measure oxygen level in blood) measurement is expensive, time-consuming, and painful. Continuous respiratory rate monitoring is possible, and has been considered the gold standard of apnea detection (seeing stopped breathing), yet is seldom used. As a result of these limitations, there is currently no simple, cost-effective, and reliable means of detecting hypoventilation in this patient population either in the recovery room or inpatient unit. Transcutaneous (across the skin) pCO2 (t-pCO2) monitoring has been validated as a reliable and reproducible means of measuring pCO2 in newborn babies, and recently has also been used in adults, primarily in the ICU (intensive care unit) setting. When compared to standard end-tidal CO2 measurement, t-pCO2 correlates better with pCO2 in the intraoperative period in both thin and obese patients. SenTec, is the manufacturer of a device used to measure t-pCO2 for this project. This study is designed to detect the incidence of hypercapnea in morbidly obese post-surgical bariatric patients in the postoperative period using the SenTec t-pCO2 monitor.
Objective:To determine the incidence of hypoventilation and hypercapnea as measured by transcutaneous pCO2 monitoring in post-surgical bariatric patients as compared to thin controls.
- Conditions
- Bariatric Patients
- Being tested
- Sentec monitoring device, sentec monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentec monitoring deviceDevice
Sentec monitor applied transcutaneously to forehead
sentec monitorDevice
Also called Sentec monitoring device
transcutaneous monitoring
| Study group | Role | What they receive |
|---|---|---|
| morbidly obese | BMI >45 Receives: Device: Sentec monitoring device; Device: sentec monitor | |
| thin patients | BMI <45 Receives: Device: Sentec monitoring device; Device: sentec monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of hypoventilation and hypercapnea as measured by transcutaneous pCO2 monitoring in post surgical bariatric patients as compared to thin controls.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric PatientsStudies of the same condition, open and under way.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy Soto, MD, Corewell Health East
- Investigators
- Roy Soto, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248312
- Sponsor's protocol ID
- 2010-208
- Status last verified
- Aug 2012
- First submitted
- 17 Nov 2010
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Incidence of Hypercapnea in Morbidly Obese Post-Surgical Patients Using the Sen Tec Transcutaneous PCO2 Monitor
- ClinicalTrials.gov ID
- NCT01248312
- Acronym / sponsor ID
- 2010-208
- Conditions
- Bariatric Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Nov 2010 (estimated)
- 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.
Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon dioxide is a gaseous product of the body's metabolism and is normally expelled through the lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the ventilation is inadequate to perform needed gas exchange; therefore resulting in decreased levels of oxygen and increased levels of carbon dioxide in the blood. It can cause an increased concentration of carbon dioxide and respiratory acidosis. Obesity is a multi-system disorder, particularly involving the respiratory (lungs/breathing) and cardiovascular (heart/vessel) systems. Obesity increases the risks for surgical and anesthetic complications before, during and following surgery.
Bariatric (weight loss) surgery is becoming a common procedure among the morbidly obese (100 lbs or more above normal weight), with recent studies highlighting the long-term health implications of surgical weight reduction, to include a decreased risk of hypertension (high blood pressure) and diabetes (increased sugar in blood). Obese patients are at increased risk of sleep apnea (stop breathing while asleep) and hypoventilation even without surgery, and these risks increase following administration of medications typically given during and after major surgical procedures. Hypoventilation can lead to hypercapnea, sedation (sleepiness), and acidosis (blood imbalance), resulting in further respiratory compromise (breathing problems) and cardiac morbidity (heart problems) as well as the risks inherent in re-intubating (needing to have a breathing tube place down into the lungs) the obese.Monitoring for hypoventilation can be difficult. Quantitative capnography (measuring carbon dioxide) is only appropriate for intubated patients (on a ventilator - breathing tube), and pulse oximetry (clip on finger that measures oxygen levels) does not adequately detect hypoventilation in patients receiving supplemental (additional) oxygen. Serial arterial blood gas (blood taken from an artery to measure oxygen level in blood) measurement is expensive, time-consuming, and painful. Continuous respiratory rate monitoring is possible, and has been considered the gold standard of apnea detection (seeing stopped breathing), yet is seldom used. As a result of these limitations, there is currently no simple, cost-effective, and reliable means of detecting hypoventilation in this patient population either in the recovery room or inpatient unit. Transcutaneous (across the skin) pCO2 (t-pCO2) monitoring has been validated as a reliable and reproducible means of measuring pCO2 in newborn babies, and recently has also been used in adults, primarily in the ICU (intensive care unit) setting. When compared to standard end-tidal CO2 measurement, t-pCO2 correlates better with pCO2 in the intraoperative period in both thin and obese patients. SenTec, is the manufacturer of a device used to measure t-pCO2 for this project. This study is designed to detect the incidence of hypercapnea in morbidly obese post-surgical bariatric patients in the postoperative period using the SenTec t-pCO2 monitor.
Objective:To determine the incidence of hypoventilation and hypercapnea as measured by transcutaneous pCO2 monitoring in post-surgical bariatric patients as compared to thin controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morbidly obese | – | Device: Sentec monitoring device, Device: sentec monitorBMI >45 |
| thin patients | – | Device: Sentec monitoring device, Device: sentec monitorBMI <45 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 morbidly obese post surgical laparoscopic bariatric patients and 10 thin subjects undergoing laparoscopic procedures
Key inclusion criteria (2 listed)
- Consenting male or female adults aged 18-65, scheduled to undergo elective laparoscopic gastric bypass (morbidly obese) or patients scheduled to undergo an abdominal procedure (thin) which will similarly require an overnight admission to Beaumont/Royal Oak Hospital
- Women must be nonpregnant and nonlactating, postmenopausal or surgically sterile. Women of childbearing age must have a negative pregnancy test (performed per standard hospital protocol
Key exclusion criteria (6 listed)
- History of COPD (lung/breathing disease)
- Home O2 (oxygen) dependence (home CPAP use is acceptable)
- Pregnancy/nursing
- Scheduled to receive epidural pain management.(Epidural pain management is the continuous infusion of medication(s) into the space surrounding the spinal cord called the epidural space.)
- Participation in another clinical trial within the past 30days
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 |
|---|---|---|
| Sentec monitoring deviceSentec monitor applied transcutaneously to forehead | Device | morbidly obese, thin patients |
| sentec monitorAlso: Sentec monitoring devicetranscutaneous monitoring | Device | morbidly obese, thin patients |
Primary outcome
To determine the incidence of hypoventilation and hypercapnea as measured by transcutaneous pCO2 monitoring in post surgical bariatric patients as compared to thin controls.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
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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.
Roy Soto, MD principal investigator
Corewell Health East
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 Bariatric Patients, run by Corewell Health East 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 20 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of hypoventilation and hypercapnea as measured by transcutaneous pCO2 monitoring in post surgical bariatric patients as compared to thin controls. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2012.