Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

Upper Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524614
• Other study ID #: 2010p002823
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 15, 2017
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Upper Airway Obstruction

Intervention

Procedure:
• nasal mask
nasal mask use instead of face mask

Locations

Country	Name	City	State
United States	Anesthesia and Critical Care, Mass General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expired tidal volume	Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.	Average of one minute after anesthesia induction
Secondary	volume of CO2	Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.	Average of one minute after anesthesia induction