Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

NCT02104453 | Unknown

• 2 other identifiers: 1-103-05-029WChan
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Morbidity

Keywords

airway maneuver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hemodynamic change

  during anesthesia induction

Study Arms (3)

E-C clamp mask holding technique

EXPERIMENTAL

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

two-handed ventilation with jaw thrust

EXPERIMENTAL

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

Procedure: airway maneuver

triple airway maneuver

EXPERIMENTAL

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

Procedure: airway maneuver

Interventions

airway maneuver 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)

E-C clamp mask holding technique; triple airway maneuver; two-handed ventilation with jaw thrust

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 114, Taiwan

RECRUITING

Study Officials

• Chan, doctorate

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Department, Tri-Service General Hospital

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 4, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

TW (1)