"Neutral Position" and "Head-elevating Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults

Intubation; Difficult Clinical Trial

Official title:

"Neutral Position" and "Head-elevating Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578992
• Other study ID #: 2-103-05-125
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: October 25, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• 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

The purpose of this study is to investigate two different patient's head and neck positions(neutral position and head-elevating position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

Description:

Placing the patient's head and neck in an proper position before laryngoscopy or intubation is a very important maneuver for facilitating a successful intubation. Recently, the video optical intubating stylet is developed as an alternative device for tracheal intubation which is preloaded with a tracheal tube and allows to view the tube advancement by the video monitor. Since the approach of glottic view and the field of view with the video intubating stylet is different from a direct laryngoscopy, the optimal patient's head and neck position for intubating stylet may also be different. The purpose of this study is to investigate two different patient's head and neck positions(neutral position and head-elevating position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients scheduled for various surgeries requiring general anesthesia with tracheal intubation

• American Society of Anesthesiologists(ASA) physical status classification I-III

Exclusion Criteria:

• pneumothorax

• room air saturation by pulse oximeter saturation less than 96%

• vocal cord palsy

• craniofacial anomaly

• congenital upper airway anomaly

• upper airway disease

• cervical spine pathology

• head and neck tumor status post radiotherapy

• an increased risk of regurgitation or pulmonary aspiration

• a history of difficult tracheal intubation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Procedure:
• Head-elevating position
A 7 cm high pillow was set beneath the patients' head with head extension position for intubation.

Device:
• 7cm high pillow
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.

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	intubation time	the interval from the intubating stylet touched the mouth to the tracheal tube cuff inflated, was recorded by an independent observer with a stop watch.	from the intubating stylet touched the mouth to the tracheal tube cuff inflated, up to 40 seconds	No
Secondary	modified Cormack-Lehane grade	The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.	during intubation, after epiglottis was identified on the video monitor	No
Secondary	Contributing factors influencing intubation time	record patient's sex, age, weight, height, clinical history, length of upper incisors, relationship of maxillary and mandibular incisors during normal jaw closure, modified Mallampati grading, tongue width, interincisor distance, mental-hyoid distance, hyoid-thyroid distance, thyromental distance, sternomental distance, neck length(sternocleidomastoid muscle length), neck circumference (measured at the thyroid cartilage level), and neck movement(from maximal flexion to maximal extension).	before intubation, up to 5 minutes	No