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

NCT01248312 | Completed DMC

• 1 other identifier: 2010-208
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (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.

  one year

Study Arms (2)

morbidly obese

BMI \>45

Device: Sentec monitoring device; Device: sentec monitor

thin patients

BMI \<45

Device: Sentec monitoring device; Device: sentec monitor

Interventions

Sentec monitoring device DEVICE

Sentec monitor applied transcutaneously to forehead

morbidly obese; thin patients

sentec monitor DEVICE

transcutaneous monitoring

Also known as: Sentec monitoring device

morbidly obese; thin patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Study Officials

• Roy Soto, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 25, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 20, 2012

Record last verified: 2012-08

Locations

US (1)