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Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

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ClinicalTrials.gov Identifier: NCT02104453
Recruitment Status : Unknown
Verified November 2014 by Wei-Hung Chan, Tri-Service General Hospital.
Recruitment status was:  Recruiting
First Posted : April 4, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Wei-Hung Chan, Tri-Service General Hospital

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.

Condition or disease Intervention/treatment Phase
Airway Morbidity Procedure: airway maneuver Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

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)





Primary Outcome Measures :
  1. Air exchange [ Time Frame: during anesthesia induction ]
    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 :
  1. Hemodynamic change [ Time Frame: during anesthesia induction ]
    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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104453


Locations
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Taiwan
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Chan, Unervisity    886-2-87923311 ext 12963    whcken@gmail.com   
Principal Investigator: Chan, Doctorate         
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Chan, doctorate Tri-Service General Hospital

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Responsible Party: Wei-Hung Chan, Anesthesiology Department, Tri-Service General Hospital, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02104453     History of Changes
Other Study ID Numbers: 1-103-05-029
WChan ( Registry Identifier: WChan )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Wei-Hung Chan, Tri-Service General Hospital:
airway maneuver
Additional relevant MeSH terms:
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Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms