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

NCT ID: NCT02578992

Last Updated: 2016-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-10-31

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.

Conditions

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Intubation; Difficult

Keywords

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intubating stylet head and neck position

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Head-lift position

Intervention Type PROCEDURE

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

7cm high pillow

Intervention Type DEVICE

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Head-lift position

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

Intervention Type PROCEDURE

7cm high pillow

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

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei-Hung Chan

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tri-Service General Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2-103-05-125

Identifier Type: -

Identifier Source: org_study_id