NCT02364622

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
Last Updated

February 18, 2015

Status Verified

October 1, 2013

Enrollment Period

1.2 years

First QC Date

February 10, 2015

Last Update Submit

February 17, 2015

Conditions

Intubation ComplicationIntubation, Difficult

Keywords

flexible intubating styletdouble-lumen endobronchial tube

Outcome Measures

Primary Outcomes (1)

  • Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea

    12 month

Secondary Outcomes (6)

  • The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea

    12 month

  • The outcome measure is mean blood pressure (MAP) during intubation period

    12 month

  • The outcome measure is the heart rate (HR) during intubation period

    12 month

  • The outcome measure is the incidence of hypoxemia

    12 month

  • The outcome measure is the incidence of sore throat

    12 month

  • +1 more secondary outcomes

Study Arms (3)

Tranditional fiberoptic bronchoscopy

SHAM COMPARATOR

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

Device: Tranditional fiberoptic bronchoscopy

Modified fiberoptic bronchoscopy

EXPERIMENTAL

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

Device: Modified fiberoptic bronchoscopy

Flexible Trachway intubating stylet

EXPERIMENTAL

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

Device: Flexible Trachway intubating stylet

Interventions

Tranditional fiberoptic bronchoscopyDEVICE

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

Tranditional fiberoptic bronchoscopy
Modified fiberoptic bronchoscopyDEVICE

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

Modified fiberoptic bronchoscopy
Flexible Trachway intubating styletDEVICE

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

Flexible Trachway intubating stylet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 803, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35971080DERIVED

Study Officials

  • Hung-Te Hsu, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 18, 2015

Record last verified: 2013-10

Locations

TW(1)