Head Position for Endotracheal Intubation

Intubation; Difficult Clinical Trial

— THHEIEIA  

Official title:

The Degree of Neck Flexion Does Not Influence on the Laryngeal View and Discomfort During Endotracheal Intubation in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418741
• Other study ID #: H-1312/037-002
• Status: Completed
• Phase: N/A
• First received: October 12, 2014
• Last updated: April 18, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: National Medical Center, Seoul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.

Description:

The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Elective operation time =2hrs

• American Society of Anesthesiologist, Physical Status 1 or 2

• age ; 18 - 90 years

Exclusion Criteria:

• patient has upper respiratory infection symptoms

• limited mouth opening

• teeth problems

• expecting difficult airway

• congenital heart disease

• patient has a possibility of aspiration pneumonia

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Other:
• Neck flexion
Patient's neck was flexed using a 4 cm or 8 cm height of pillow

Locations

Country	Name	City	State
Korea, Republic of	National Medical Center	Seoul	Junggu

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Center, Seoul

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laryngeal view as index of ease of insertion	Cormack Lehane grade during endotracheal intubation	one year	Yes
Secondary	Discomfort of anesthesiologist during endotracheal intubation	Anesthesiologist can feel difficulties in mouth opening and in insertion of laryngoscopic blade into oral cavity according to the degrees of neck flexion	one year	Yes