Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Incidence of Hypercapnea in Morbidly Obese Post-Surgical Bariatric Patients Using the Sen Tec Transcutaneous PCO2 Monitor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roy Soto, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01248312
First received: November 17, 2010
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Bariatric Patients
Device: Sentec monitoring device
Device: sentec monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimation of the Incidence of Hypercapnea in Morbidly Obese Post-Surgical Patients Using the Sen Tec Transcutaneous PCO2 Monitor

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
morbidly obese
BMI >45
Device: Sentec monitoring device
Sentec monitor applied transcutaneously to forehead
Device: sentec monitor
transcutaneous monitoring
Other Name: Sentec monitoring device
thin patients
BMI <45
Device: Sentec monitoring device
Sentec monitor applied transcutaneously to forehead
Device: sentec monitor
transcutaneous monitoring
Other Name: Sentec monitoring device

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

10 morbidly obese post surgical laparoscopic bariatric patients and 10 thin subjects undergoing laparoscopic procedures

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248312

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Roy Soto, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Roy Soto, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01248312     History of Changes
Other Study ID Numbers: 2010-208
Study First Received: November 17, 2010
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2014