Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:2/7/2015
Start Date:October 2011
Contact:Yandong Jiang, MD, PhD
Email:YJIANG@PARTNERS.ORG
Phone:617-724-2250

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Effect of Continuous Positive Airway Pressure Ventilation Through Nasal Mask on Upper Airway Patency During Induction of Anesthesia

Upper airway obstruction (UAO) is common complication during induction of general
anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior
displacement of soft palate are believed to be the primary contributing factors. The
mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea
(OSA). Since nasal continuous positive airway pressure (nCPAP) can maintain the airway
patent in patients with OSA, the investigators hypothesize that nCPAP during induction of
anesthesia will reduce the incidence and severity of UAO.


Inclusion Criteria:

Patients,between 18-65 years of age meeting ASA physical status classification I-II
requiring general anesthesia for elective surgery who are able to breathe through both
their nose and mouth while awake.

Exclusion Criteria:

1. Patients with major cardiovascular disease, respiratory disease, cerebral vascular
disease or American Society of Anesthesiologists physical status class III or
greater.

2. 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.

3. Unable to open mouth (< 2.5 cm) or unable to breathe through their mouth or nose.

4. Subjects with a beard, an abnormal facial structure or other factors precluding
obtaining a viable face mask fit without air leak. Also, subjects having
claustrophobia that can not tolerate the mask.

5. Any person with an anticipated difficult airway. This will include subjects who
require or may require either a fiberoptic intubation or intubation while awake and
subjects with known OSA or body mass index (BMI) greater than 35 km/m2.

6. Gastric-esophageal reflex or a full stomach.

7. The subject has remained in bed for more than 24 hours.

8. 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.

9. 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.

10. Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os)
guidelines.
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