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CompletedNCT01524614Updated Jan 18, 2017

Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

An interventional study of nasal mask in Upper Airway Obstruction, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Upper Airway Obstruction

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Keywords

  • continuous positive airway pressure
  • nasal mask
  • upper airway obstruction
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In context

Airway Obstruction

154 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.

This study's enrollment of 80 is above the median of 56 across 92 interventional studies indexed under Airway Obstruction.

Browse Airway Obstruction studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Nasal mask with no PEEP

    Nasal mask with PEEP 0, then add PEEP 5, and 10

    Procedure: nasal mask

  • Experimental
    Nasal mask with PEEP

    Nasal mask with PEEP 5, then add PEEP 10

    Procedure: nasal mask

  • Experimental
    Face mask with no PEEP

    Face mask with PEEP 0 then add PEEP 5, 10

    Procedure: nasal mask

  • Experimental
    Face mask with PEEP

    Face mask with PEEP 5, then add PEEP 10

    Procedure: nasal mask

Interventions

  • Procedurenasal mask

    nasal mask use instead of face mask

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What researchers measure

Primary outcomes

  1. expired tidal volume

    Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.

    Time frame: Average of one minute after anesthesia induction

Secondary outcomes

  1. volume of CO2

    Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.

    Time frame: Average of one minute after anesthesia induction

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Study locations

1 site
  • Anesthesia and Critical Care, Mass General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

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. PubMed 24365207 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01524614
Lead sponsor
Massachusetts General Hospital
Responsible party
Yandong Jiang (Assistant Professor, Massachusetts General Hospital) — Principal investigator
First posted
Feb 2, 2012
Start date
Oct 2011
Primary completion
May 2012
Completion
May 2012
Last update
Jan 18, 2017

Study contacts

Yandong Jiang, MD, PhD
principal investigator · Mass. General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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