Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

NCT ID: NCT02104453

Last Updated: 2014-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Airway Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

airway maneuver

Intervention Type: PROCEDURE

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)

two-handed ventilation with jaw thrust

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

Group Type: EXPERIMENTAL

airway maneuver

Intervention Type: PROCEDURE

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)

triple airway maneuver

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

Group Type: EXPERIMENTAL

airway maneuver

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei-Hung Chan

Anesthesiology Department, Tri-Service General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chan, doctorate

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Chan, Unervisity

Role: primary

whcken@gmail.com

886-2-87923311 ext. 12963

Other Identifiers

WChan

Identifier Type: REGISTRY

Identifier Source: secondary_id

1-103-05-029

Identifier Type: -

Identifier Source: org_study_id