The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube

NCT ID: NCT02364622

Last Updated: 2015-02-18

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.

Detailed Description

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How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.

Conditions

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Intubation Complication Intubation, Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tranditional fiberoptic bronchoscopy

The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy.

Group Type SHAM_COMPARATOR

Tranditional fiberoptic bronchoscopy

Intervention Type DEVICE

The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.

Modified fiberoptic bronchoscopy

The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy.

Group Type EXPERIMENTAL

Modified fiberoptic bronchoscopy

Intervention Type DEVICE

The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy

Flexible Trachway intubating stylet

We used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus.

Group Type EXPERIMENTAL

Flexible Trachway intubating stylet

Intervention Type DEVICE

The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.

Interventions

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Tranditional fiberoptic bronchoscopy

The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.

Intervention Type DEVICE

Modified fiberoptic bronchoscopy

The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy

Intervention Type DEVICE

Flexible Trachway intubating stylet

The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* risk of regurgitation and pulmonary aspiration
* history of gastroesophageal reflux, pregnancy
* scheduled tracheostomy and postoperative prolonged ventilation in ICU
* patients with limited neck extension (\< 35°)
* a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
* a sternomental distance of less than 12.5 cm with the head fully extended
* 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, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Kaohsiung Medical University chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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Hsu HT, Kuo YW, Ma CW, Su MP, Tseng KY, Li CL, Cheng KI. Trachway(R) flexible stylet facilitates the correct placement of double-lumen endobronchial tube: a prospective, randomized study. BMC Anesthesiol. 2022 Aug 15;22(1):260. doi: 10.1186/s12871-022-01800-8.

Reference Type DERIVED
PMID: 35971080 (View on PubMed)

Other Identifiers

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KMUH-IRB-20130194

Identifier Type: -

Identifier Source: org_study_id

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