Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01524614
First received: January 12, 2012
Last updated: January 23, 2014
Last verified: January 2014

January 12, 2012
January 23, 2014
October 2011
May 2012   (final data collection date for primary outcome measure)
expired tidal volume [ Time Frame: Average of one minute after anesthesia induction ] [ Designated as safety issue: Yes ]
Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
Same as current
Complete list of historical versions of study NCT01524614 on ClinicalTrials.gov Archive Site
volume of CO2 [ Time Frame: Average of one minute after anesthesia induction ] [ Designated as safety issue: No ]
Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Upper Airway Obstruction
Procedure: nasal mask
nasal mask use instead of face mask
  • Experimental: Nasal mask with no PEEP
    Nasal mask with PEEP 0, then add PEEP 5, and 10
    Intervention: Procedure: nasal mask
  • Experimental: Nasal mask with PEEP
    Nasal mask with PEEP 5, then add PEEP 10
    Intervention: Procedure: nasal mask
  • Experimental: Face mask with no PEEP
    Face mask with PEEP 0 then add PEEP 5, 10
    Intervention: Procedure: nasal mask
  • Experimental: Face mask with PEEP
    Face mask with PEEP 5, then add PEEP 10
    Intervention: Procedure: nasal mask
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Yandong Jiang, MD, PhD 617-724-2250 YJIANG@PARTNERS.ORG
Contact: Jun Oto, MD, PhD 617-724-4496 JOTO@PARTNERS.ORG
United States
 
NCT01524614
2010p002823
Yes
Yandong Jiang, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Yandong Jiang, MD, PhD Mass General Hospital
Massachusetts General Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP