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
  Purpose

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.


Condition Intervention
Upper Airway Obstruction
Procedure: nasal mask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effect of Continuous Positive Airway Pressure Ventilation Through Nasal Mask on Upper Airway Patency During Induction of Anesthesia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: October 2011
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524614

Contacts
Contact: Yandong Jiang, MD, PhD 617-724-2250 YJIANG@PARTNERS.ORG
Contact: Jun Oto, MD, PhD 617-724-4496 JOTO@PARTNERS.ORG

Locations
United States, Massachusetts
Anesthesia and Critical Care, Mass General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yandong Jiang, MD, PhD    617-724-2236    YJIANG@PARTNERS.ORG   
Contact: Jun Oto, MD, PhD    617-724-4496    JOTO@PARTNERS.ORG   
Principal Investigator: Yandong Jiang, MD, PhD         
Sub-Investigator: Jun Oto, MD, PhD         
Sub-Investigator: William R Kimball, MD, PhD         
Sub-Investigator: Robert M Kacmarek, PhD         
Sub-Investigator: Demet Sulemanji, MD, PhD         
Sub-Investigator: Yanhong Liu, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Yandong Jiang, MD, PhD Mass General Hospital
  More Information

No publications provided

Responsible Party: Yandong Jiang, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01524614     History of Changes
Other Study ID Numbers: 2010p002823
Study First Received: January 12, 2012
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
continuous positive airway pressure
nasal mask
upper airway obstruction

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014