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The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

NCT ID: NCT01517204

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

Detailed Description

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Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.

The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

Conditions

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Anesthesia Intubation Complications

Keywords

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Trachway(R) intubating stylet Left sided double lumen endobronchial tube Efficacy Intubation complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Direct laryngoscope

Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube.

Group Type EXPERIMENTAL

Direct laryngoscope (Macintoish laryngoscope)

Intervention Type DEVICE

Direct laryngoscope was used to facilitate the intubation of left-sided DLT.

Trachway(R) intubating stylet

Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation.

Group Type EXPERIMENTAL

Trachway(R) intubating stylet

Intervention Type DEVICE

Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.

Interventions

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Direct laryngoscope (Macintoish laryngoscope)

Direct laryngoscope was used to facilitate the intubation of left-sided DLT.

Intervention Type DEVICE

Trachway(R) intubating stylet

Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.

Intervention Type DEVICE

Other Intervention Names

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Macintoish laryngoscope The Clarus Video System

Eligibility Criteria

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Inclusion Criteria

1. patients with American Society of Anesthesiologists physical status I-III
2. More than 18 years of age
3. Requiring DLT for thoracic surgery

Exclusion Criteria

1. risk of regurgitation and pulmonary aspiration
2. history of gastroesophageal reflux, pregnancy
3. scheduled tracheostomy and postoperative prolonged ventilation in ICU
4. patients with limited neck extension (\< 35°)
5. a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
6. a sternomental distance of less than 12.5 cm with the head fully extended
7. mouth can not open
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung-Te Hsu, VS

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesia, Kaoshiung medical university hospital

Locations

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department of anesthesia, Kaohsiung medical university memorial hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUH-IRB-990305

Identifier Type: -

Identifier Source: org_study_id