Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

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.

Study Overview

• Status: Completed
• Conditions: Upper Airway Obstruction
• Intervention / Treatment: Procedure: nasal mask

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Anesthesia and Critical Care, Mass General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal mask with no PEEP; Nasal mask with PEEP 0, then add PEEP 5, and 10	Procedure: nasal mask; nasal mask use instead of face mask
Experimental: Nasal mask with PEEP; Nasal mask with PEEP 5, then add PEEP 10	Procedure: nasal mask; nasal mask use instead of face mask
Experimental: Face mask with no PEEP; Face mask with PEEP 0 then add PEEP 5, 10	Procedure: nasal mask; nasal mask use instead of face mask
Experimental: Face mask with PEEP; Face mask with PEEP 5, then add PEEP 10	Procedure: nasal mask; nasal mask use instead of face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Yandong Jiang, MD, PhD, Mass. General Hospital

Publications and helpful links

General Publications

• Oto J, Li Q, Kimball WR, Wang J, Sabouri AS, Harrell PG, Kacmarek RM, Jiang Y. Continuous positive airway pressure and ventilation are more effective with a nasal mask than a full face mask in unconscious subjects: a randomized controlled trial. Crit Care. 2013 Dec 23;17(6):R300. doi: 10.1186/cc13169.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 15, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: continuous positive airway pressure; nasal mask; upper airway obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 2010p002823