Incidence of Hypercapnea in Morbidly Obese Post-Surgical Bariatric Patients Using the Sen Tec Transcutaneous PCO2 Monitor
Public ClinicalTrials.gov record NCT01248312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Estimation of the Incidence of Hypercapnea in Morbidly Obese Post-Surgical Patients Using the Sen Tec Transcutaneous PCO2 Monitor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01248312
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Jul 31, 2012
- Completion
- Jul 31, 2012
- Last update posted
- Aug 19, 2012
2010 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01248312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2012 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01248312 live on ClinicalTrials.gov.