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Nasal Mask Ventilation During the Induction of General Anesthesia

Primary Purpose

Mechanical Ventilation Complication, Upper Airway Obstruction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nasal mask
full face mask
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mechanical Ventilation Complication focused on measuring General anesthesia, Positive-pressure ventilation, Masks

Eligibility Criteria

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

Inclusion Criteria:

  • 18-65 years of age
  • ASA physical status classification I-II
  • general anesthesia
  • 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.
  • Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
  • Gastric-esophageal reflex or a full stomach.
  • 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 - Nothing By Mouth) guidelines.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nasal mask

full face mask

Arm Description

when the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask.

when the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask.

Outcomes

Primary Outcome Measures

Tidal volume
Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia

Secondary Outcome Measures

Carbon dioxide removal
carbon dioxide removed per minute during the induction of general anesthesia will be calculated
success rate of positive pressure ventilation with different masks

Full Information

First Posted
June 6, 2012
Last Updated
January 15, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01651286
Brief Title
Nasal Mask Ventilation During the Induction of General Anesthesia
Official Title
Determination of the Efficacy of Nasal Mask Ventilation During the Induction of General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Upper Airway Obstruction
Keywords
General anesthesia, Positive-pressure ventilation, Masks

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nasal mask
Arm Type
Experimental
Arm Description
when the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask.
Arm Title
full face mask
Arm Type
Active Comparator
Arm Description
when the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask.
Intervention Type
Procedure
Intervention Name(s)
nasal mask
Intervention Description
Using the nasal mask instead of the full face mask during the induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
full face mask
Intervention Description
using a standard full face mask during the induction of general anesthesia.
Primary Outcome Measure Information:
Title
Tidal volume
Description
Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia
Time Frame
in 30 minutes after the induction of general anesthesia
Secondary Outcome Measure Information:
Title
Carbon dioxide removal
Description
carbon dioxide removed per minute during the induction of general anesthesia will be calculated
Time Frame
in 30 minutes after the induction of general anesthesia
Title
success rate of positive pressure ventilation with different masks
Time Frame
in 30 minute after the induction of general anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age ASA physical status classification I-II general anesthesia 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. Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake. Gastric-esophageal reflex or a full stomach. 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 - Nothing By Mouth) guidelines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hovig V Chitilian, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yandong Jiang, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Nasal Mask Ventilation During the Induction of General Anesthesia

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