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

Not Applicable
Completed
Conditions
Intubation; Difficult
Interventions
Procedure: Head-lift position
Device: 7cm high pillow
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.

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
Arm && Interventions
GroupInterventionDescription
Head-lift PositionHead-lift positionThe 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
Head-lift Position7cm high pillowThe 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
Primary Outcome Measures
NameTimeMethod
Intubation Timefrom 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
NameTimeMethod
Modified Cormack-Lehane Gradeduring 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 Pressurebefore and after intubation, up to 5 minutes

compare the mean arterial pressure between two groups.

Visual Analog Scale of Sore Throatafter 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

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