Effect of Body Positioning on Upper Airway Patency During Induction of Anesthesia in Obese Patients

Completed

Conditions studied: Obese

In brief

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 obstruction observed during obstructive sleep apnea (OSA). Obesity is major risk factors for OSA and obese patients have a higher prevalence of UAO during anesthesia. The change of body position improved upper airway stability during sleep in patients with OSA.We hypothesis that the 30˚ reverse trendelenburg body position maintain airway patency in obese patients during general anesthesia.

Key facts

Study ID

NCT01811069

Run by

Massachusetts General Hospital

People needed

13

Starts

2013-04-01

Expected to finish

2014-01-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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