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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT01248312
Study groupRoleWhat they receive
morbidly obeseBMI >45
Receives: Device: Sentec monitoring device; Device: sentec monitor
thin patientsBMI <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.

  1. 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.

  1. First posted25 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

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)
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

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.

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