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

NCT01811069 | Completed DMC

• 1 other identifier: 2012p-002632
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obese

Keywords

Obese patients; Upper airway patency

Outcome Measures

Primary Outcomes (1)

• expired tidal volume

  The ventilation will continue for 1 min in flat position and then, operating table will be changed to 30˚ reverse trendelenburg position and the ventilation will continue for 1 min. Then, operating table will leveled and the ventilation will continue for 1 min.

  5 minutes

Secondary Outcomes (1)

• Vte/Area under the Curve (AUC) of the pressure trace during mask ventilation

  5 minutes

Interventions

Head up PROCEDURE

30˚ reverse trendelenburg body position

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fifteen patients 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 requiring general anesthesia for elective surgery

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)