Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

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

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.

Study Overview

• Status: Unknown
• Conditions: Airway Morbidity
• Intervention / Treatment: Procedure: airway maneuver

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Chan, Unervisity; Phone Number: 12963 886-2-87923311; Email: whcken@gmail.com
    • Principal Investigator: Chan, Doctorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-C clamp mask holding technique; 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.	Procedure: airway maneuver; 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)
Experimental: two-handed ventilation with jaw thrust; the airway maneuver performed with thumbs point toward feet, palms press down and other fingers perform jaw thrust	Procedure: airway maneuver; 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)
Experimental: triple airway maneuver; the airway maneuver performed with two-handed mask ventilation, jaw thrust and head-tilt chin-lift technique	Procedure: airway maneuver; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during anesthesia induction

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Chan, doctorate, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: airway maneuver
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness
• Other Study ID Numbers: 1-103-05-029; WChan (Registry Identifier: WChan)