Status:
COMPLETED
Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Obese
Eligibility:
All Genders
18-65 years
Brief Summary
Upper airway obstruction (UAO) during induction of general anesthesia is a frequently occurring complication. The mechanism of UAO during anesthesia shares many similarities with the upper airway obst...
Detailed Description
This is a prospective, observational study. Fifteen subjects with BMI limited in the range of 30 kg/m2 to 50 kg/m2, between 18-65 years of age meeting ASA physical status classification I-III requirin...
Eligibility Criteria
Inclusion
- BMI limited in the range of 30 kg/ m2 to 50 kg/ m2, 18-65 years of age ASA physical status classification I-III Requiring general anesthesia for elective surgery -
Exclusion
- Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class IV or greater.
- Abnormal vital signs on the day of admission for surgery \[heart rate (HR, \>100 bpm or \< 40 bpm), blood pressure (BP, \>180/100 mmHg or \< 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) \< 96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication.
- Having claustrophobia and not able to tolerate the mask.
- Any person with an anticipated difficult airway or those with a history of difficult airway who requires a fiberoptic intubation while awake.
- Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.
- The subject has been in bed for more than 24 hours.
- Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
- Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
- Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.
- \-
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01811069
Start Date
April 1 2013
End Date
January 1 2014
Last Update
January 18 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114