The Optimum Time for Preoxygenation Based on Body Mass Index

Obesity Clinical Trial

Official title:

The Optimum Time for Preoxygenation Based on Body Mass Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114932
• Other study ID #: Pro00011544
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: February 14, 2012
• Start date: July 2007
• Est. completion date: October 2009

Study information

• Verified date: February 2012
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Obesity

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No