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

Tri-Service General Hospital130 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Intubation; Difficult

Interventions

Head-lift positionPROCEDURE

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

7cm high pillowDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts

Secondary Outcomes

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.

Time frame: during intubation, after epiglottis was identified on the video monitor

Mean Arterial Pressure

compare the mean arterial pressure between two groups.

Time frame: 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.

Time frame: after anesthesia emergence 30 minutest, at post-anesthesia care unit

Data from ClinicalTrials.gov

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