The Optimum Time for Preoxygenation Based on Body Mass Index
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Purpose
The purpose of this study is to evaluate the relationship between the time needed to raise the oxygen concentration in patient's blood to 90% and his/or her body mass index. The prevalence of obesity in our society continues to rise. No studies have shown the time required for preoxygenation (oxygen given) in relation to body mass index (body weight in kg/height in meter2).
| Condition |
|---|
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Body Weight Obesity |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Optimum Time for Preoxygenation Based on Body Mass Index |
- Time to reach 90% end tidal oxygen saturation using monitor and stop watch [ Time Frame: 1 to 10 minutes ] [ Designated as safety issue: No ]Using monitors on the anesthesia machine, we recorded the end tidal oxygen saturation value and also recorded the time at which the end tidal oxygen was recorded. From the information collected the relationship between BMI and gender with the time to 90% end tidal oxygen saturation will be evaluated.
| Enrollment: | 75 |
| Study Start Date: | July 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
BMI-I
Patients with BMI values between 18.5-24.9
|
|
BMI-II
Patients with BMI values between 25-29.9
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BMI-III
Patients with BMI values between 30-49.9
|
Detailed Description:
100% oxygen given to patient before induction of anesthesia (asleep) is the standard clinical care. However, studies using various methods have shown differences in terms of the optimal time, technique and number of breaths needed for efficient oxygenation. The only difference to the standard pre-anesthesia care is that we will record the time to raise patient oxygen to 90%. Age is recorded to ensure that the subjects fall within our inclusion criteria. The weight (W) in kilograms and height (H) in meters will be used to calculate the body mass index (BMI): BMI = W/H2. Alveolar oxygen uptake is dependent on respiratory rate, heart rate, blood pressure, temperature and hemoglobin level. These parameters are measured in order to identify factors that may affect the accuracy of the study. We will record the pulse oximetry value to note the initial oxygen saturation on room air and after the oxygenation.
Facial hair and mask fit are recorded to assess possible failure of an optimal facemask seal. End-tidal carbon dioxide (FE'CO2) is also measured to ensure an adequate facemask seal. Anxiety can increase the respiratory rate, heart rate and affect patient compliance with a fitted facemask. All of the aforementioned values are recorded to assess reasons for possible failure of the preoxygenation technique and inaccurate results.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study population will consist of 100 subjects between the ages of 18-50 classified as ASA 1 or 2 with no limitations as to gender or race that are scheduled for elective surgery at Cedars-Sinai Medical Center. There are changes to lung functioning as functional residual capacity (FRC), closing capacity, and lung volume after age 50; therefore, the age limitation is set to age 50. Changes in lung and chest wall compliance necessitate the exclusion of anyone over the age of 50. Minors are also excluded as there is difficulty fitting the face mask due to a smaller physiology.
Inclusion Criteria:
- Participants between the ages of 18-50 years with no limitations as to gender or race
- Participants classified as ASA 1 or 2
- Participants capable of understanding and signing an informed consent
Exclusion Criteria:
- Conditions which would affect their oxygenation such as heart disease, lung disease, anemia (Hemoglobin less than 12 g/dL)
- History of smoking (smoking can affect pulmonary function and oxygen carrying capacity)
- Acute substance abuse (substance abuse can affect respiratory function).
- Maxillofacial abnormalities which would interfere with proper face mask seal.
Contacts and Locations| United States, California | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: | Roya Yumul, MD, PhD | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT01114932 History of Changes |
| Other Study ID Numbers: | Pro00011544 |
| Study First Received: | April 23, 2010 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
pre-oxygenation body mass index end-tidal O2 anesthesia induction |
Additional relevant MeSH terms:
|
Body Weight Obesity Signs and Symptoms |
Overnutrition Nutrition Disorders Overweight |
ClinicalTrials.gov processed this record on May 22, 2013