Comparative Evaluation of Three Airway Maneuvers in the Unconscious Apneic Person

Airway Morbidity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02104453
• Other study ID #: 1-103-05-029
• Secondary ID: WChan
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2014
• Last updated: November 13, 2014
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2014
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No