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

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

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

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult
• Intervention / Treatment: Procedure: Head-lift position; Device: 7cm high pillow

Detailed Description

The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head-lift Position; The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique	Procedure: Head-lift position; A 7 cm high pillow was set beneath the patients' head with head in neutral 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.
No Intervention: Neutral Position; The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Time	the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.	from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome.	during intubation, after epiglottis was identified on the video monitor
Mean Arterial Pressure	compare the mean arterial pressure between two groups.	before and after intubation, up to 5 minutes
Visual Analog Scale of Sore Throat	All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit. Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome.	after anesthesia emergence 30 minutest, at post-anesthesia care unit

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: intubating stylet; head and neck position
• Other Study ID Numbers: 2-103-05-125