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Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

Primary Purpose

Upper Airway Obstruction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

nasal mask

About this trial

This is an interventional supportive care trial for Upper Airway Obstruction focused on measuring continuous positive airway pressure, nasal mask, upper airway obstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Anesthesia and Critical Care, Mass General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Nasal mask with no PEEP

Nasal mask with PEEP

Face mask with no PEEP

Face mask with PEEP

Arm Description

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

Nasal mask with PEEP 5, then add PEEP 10

Face mask with PEEP 0 then add PEEP 5, 10

Face mask with PEEP 5, then add PEEP 10

Outcomes

Primary Outcome Measures

expired tidal volume

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

Secondary Outcome Measures

volume of CO2

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

Full Information

NCT ID

NCT01524614

First Posted

January 12, 2012

Last Updated

January 15, 2017

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01524614

Brief Title

Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

Official Title

Effect of Continuous Positive Airway Pressure Ventilation Through Nasal Mask on Upper Airway Patency During Induction of Anesthesia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Airway Obstruction

Keywords

continuous positive airway pressure, nasal mask, upper airway obstruction

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nasal mask with no PEEP

Arm Type

Experimental

Arm Description

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

Arm Title

Nasal mask with PEEP

Arm Type

Experimental

Arm Description

Nasal mask with PEEP 5, then add PEEP 10

Arm Title

Face mask with no PEEP

Arm Type

Experimental

Arm Description

Face mask with PEEP 0 then add PEEP 5, 10

Arm Title

Face mask with PEEP

Arm Type

Experimental

Arm Description

Face mask with PEEP 5, then add PEEP 10

Intervention Type

Procedure

Intervention Name(s)

nasal mask

Intervention Description

nasal mask use instead of face mask

Primary Outcome Measure Information:

Title

expired tidal volume

Description

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 Outcome Measure Information:

Title

volume of CO2

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yandong Jiang, MD, PhD

Organizational Affiliation

Mass. General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anesthesia and Critical Care, Mass General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24365207

Citation

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.

Results Reference

derived

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Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

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