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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Procedure: Head-lift position
* Device: 7cm high pillow


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head-lift Position<br>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<br>* A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.<br>Device: 7cm high pillow<br>* A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.<br>|
| No Intervention: Neutral Position<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubating stylet, head and neck position