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Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

Primary Purpose

Airway Morbidity

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
airway maneuver
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Morbidity focused on measuring airway maneuver

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients(ASA I-III) scheduled for elective surgery requiring general anesthesia with endotracheal intubation.

Exclusion Criteria:

  • pneumothorax
  • SpO2<96%(without additional oxygen supply)
  • vocal cord palsy
  • congenital airway abnormality
  • facial trauma or deformity
  • acute upper airway disease
  • inadequate fasting time
  • neck or potential cervical spine disease
  • temporal-mandible joint abnormality
  • head and neck tumor
  • status post radiotherapy
  • pregnancy
  • long term sedative or opioid drug use
  • patient refuse

Sites / Locations

  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

E-C clamp mask holding technique

two-handed ventilation with jaw thrust

triple airway maneuver

Arm Description

the airway maneuver that press the mask against the patient's face (using the "C" of our thumb and forefinger) while pulling the jaw forward (using the "E" of our other fingers behind the mandible), and leaves one hand free to squeeze the bag.

the airway maneuver performed with thumbs point toward feet, palms press down and other fingers perform jaw thrust

the airway maneuver performed with two-handed mask ventilation, jaw thrust and head-tilt chin-lift technique

Outcomes

Primary Outcome Measures

Air exchange
Expired tidal volume, end tidal CO2 slope, peak inspiratory pressure between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver

Secondary Outcome Measures

Hemodynamic change
blood pressure and heart rate variability during ventilation between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver

Full Information

First Posted
March 28, 2014
Last Updated
November 13, 2014
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02104453
Brief Title
Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person
Official Title
Comparative Evaluation of One-handed E-C Clamp Mask Holding Technique, Two-handed Mask Ventilation With Jaw Thrust, and Two-handed Mask Ventilation With Triple Airway Maneuver in the Unconscious Apneic Person
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. Sniffing position may improve ventilation between these three maneuvers. The investigators hypothesize that ventilation efficiency may be different between these three maneuvers whether the patient is in sniffing position or neutral position. The investigators would like to quantify this effect by measuring the expired tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.
Detailed Description
Mask ventilation is considered a important skill for airway management during general anesthesia induction and for apneic unconscious patients. One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. However, the efficiency of ventilation between these three maneuvers has to be clarified. Besides, whether sniffing position or neutral position may improve ventilation between these three maneuvers is to be determined. The investigators will collect airway parameters of the patients receiving general anesthesia and measure the expired tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Morbidity
Keywords
airway maneuver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-C clamp mask holding technique
Arm Type
Experimental
Arm Description
the airway maneuver that press the mask against the patient's face (using the "C" of our thumb and forefinger) while pulling the jaw forward (using the "E" of our other fingers behind the mandible), and leaves one hand free to squeeze the bag.
Arm Title
two-handed ventilation with jaw thrust
Arm Type
Experimental
Arm Description
the airway maneuver performed with thumbs point toward feet, palms press down and other fingers perform jaw thrust
Arm Title
triple airway maneuver
Arm Type
Experimental
Arm Description
the airway maneuver performed with two-handed mask ventilation, jaw thrust and head-tilt chin-lift technique
Intervention Type
Procedure
Intervention Name(s)
airway maneuver
Intervention Description
Three-period crossover study: During general anesthesia induction, subjects are assigned to one of the 6 airway maneuver sequences (ABC, CAB, BCA, ACB, CBA, or BAC) in accordance with a randomization schedule. Each maneuver is performed 5 times in a period. Airway maneuver A: E-C clamp mask holding technique; Airway maneuver B: two-handed mask ventilation with jaw thrust airway maneuver; Airway maneuver C: two-handed mask ventilation with triple airway maneuver(combine jaw thrust and head tilt chin lift)
Primary Outcome Measure Information:
Title
Air exchange
Description
Expired tidal volume, end tidal CO2 slope, peak inspiratory pressure between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver
Time Frame
during anesthesia induction
Secondary Outcome Measure Information:
Title
Hemodynamic change
Description
blood pressure and heart rate variability during ventilation between one-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver
Time Frame
during anesthesia induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients(ASA I-III) scheduled for elective surgery requiring general anesthesia with endotracheal intubation. Exclusion Criteria: pneumothorax SpO2<96%(without additional oxygen supply) vocal cord palsy congenital airway abnormality facial trauma or deformity acute upper airway disease inadequate fasting time neck or potential cervical spine disease temporal-mandible joint abnormality head and neck tumor status post radiotherapy pregnancy long term sedative or opioid drug use patient refuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chan, doctorate
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan, Unervisity
Phone
886-2-87923311
Ext
12963
Email
whcken@gmail.com
First Name & Middle Initial & Last Name & Degree
Chan, Doctorate

12. IPD Sharing Statement

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Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

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