Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

NCT01524614 | Completed DMC

• 1 other identifier: 2010p002823
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Airway Obstruction

Keywords

continuous positive airway pressure; nasal mask; upper airway obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• volume of CO2

  Average of one minute after anesthesia induction

Study Arms (4)

Nasal mask with no PEEP

EXPERIMENTAL

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

Procedure: nasal mask

Nasal mask with PEEP

EXPERIMENTAL

Nasal mask with PEEP 5, then add PEEP 10

Procedure: nasal mask

Face mask with no PEEP

EXPERIMENTAL

Face mask with PEEP 0 then add PEEP 5, 10

Procedure: nasal mask

Face mask with PEEP

EXPERIMENTAL

Face mask with PEEP 5, then add PEEP 10

Procedure: nasal mask

Interventions

nasal mask PROCEDURE

nasal mask use instead of face mask

Face mask with PEEP; Face mask with no PEEP; Nasal mask with PEEP; Nasal mask with no PEEP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
• 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.
• Unable to open mouth (\< 2.5 cm) or unable to breathe through their mouth or nose.
• 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.
• 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.
• Gastric-esophageal reflex or a full stomach.
• The subject has remained in bed for more than 24 hours.
• 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.
• 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.
• Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Anesthesia and Critical Care, Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 24365207 DERIVED

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Yandong Jiang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: February 2, 2012
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)