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

Not Applicable

Completed

• Conditions: Intubation; Difficult

• Registration Number: NCT02578992
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Results First Submitted: 2016-05-12
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Results First Posted: 2016-12-09
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intubation Time	from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts	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.

Secondary Outcome Measures

Name	Time	Method
Modified Cormack-Lehane Grade	during intubation, after epiglottis was identified on the video monitor	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.
Mean Arterial Pressure	before and after intubation, up to 5 minutes	compare the mean arterial pressure between two groups.
Visual Analog Scale of Sore Throat	after anesthesia emergence 30 minutest, at post-anesthesia care unit	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.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan