The Optimum Time for Preoxygenation Based on Body Mass Index

NCT01114932 | Completed DMC

• 1 other identifier: Pro00011544
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Body Weight; Obesity

Keywords

pre-oxygenation; body mass index; end-tidal O2; anesthesia induction

Outcome Measures

Primary Outcomes (1)

• Time to reach 90% end tidal oxygen saturation using monitor and stop watch

  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.

  1 to 10 minutes

Study Arms (3)

BMI-I

Patients with BMI values between 18.5-24.9

BMI-II

Patients with BMI values between 25-29.9

BMI-III

Patients with BMI values between 30-49.9

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Body Weight; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 3, 2010
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

US (1)