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Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation

Primary Purpose

Anesthesia Intubation Complications

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
the DLT bending to the right
the DLT bending to the left
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia Intubation Complications focused on measuring left-side double lumen bronchial tube, bending type, GlideScope videolaryngoscope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists physical status I-III
  2. more than 18 years of age
  3. Receiving thoracic surgery with double-lumen endobronchial tube

Exclusion Criteria:

  1. risk of regurgitation and pulmonary aspiration
  2. history of gastroesophageal reflux
  3. pregnancy
  4. scheduled tracheostomy and postoperative prolonged ventilation in ICU
  5. limited neck extension (< 35°)
  6. a thyromental distance less than 7 cm
  7. a sternomental distance less than 12.5 cm with the head fully extended
  8. mouth can not open

Sites / Locations

  • department of anesthesia, Kaohsiung medical university memorial hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

the DLT bending to the right

the DLT bending to the left

Arm Description

Outcomes

Primary Outcome Measures

Main outcome measure is the successful rate of the first intubation compared with the two bending modes of DLT

Secondary Outcome Measures

the time needed to insert the DLT during the period of intubation
mean blood pressure (MAP) before intubation, and after intubation 1, 3,and 5 min
the incidence of hypoxemia during the period of intubation
Hypoxemia is defined as the SPO2 is below 90%.
the heart rate (HR) before intubation, and after intubation 1, 3,and 5 min
the incidence of sore throat after extubation
the incidence of hoarseness after extubation

Full Information

First Posted
October 16, 2011
Last Updated
September 4, 2014
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01605591
Brief Title
Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation
Official Title
Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.
Detailed Description
Intubation with the double-lumen endotracheal tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as GlideScope(R) videolaryngoscope, 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 different bending type of DLT in tracheal intubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Intubation Complications
Keywords
left-side double lumen bronchial tube, bending type, GlideScope videolaryngoscope

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the DLT bending to the right
Arm Type
Active Comparator
Arm Title
the DLT bending to the left
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
the DLT bending to the right
Other Intervention Name(s)
different bending mode of DLT
Intervention Description
bending the bronchial lumen of DLT 60~90 degrees in the same side with the tracheal lumen
Intervention Type
Procedure
Intervention Name(s)
the DLT bending to the left
Other Intervention Name(s)
different bending mode of DLT
Intervention Description
bending the bronchial lumen of DLT 60~90 degree opposed to the tracheal lumen
Primary Outcome Measure Information:
Title
Main outcome measure is the successful rate of the first intubation compared with the two bending modes of DLT
Time Frame
12 month
Secondary Outcome Measure Information:
Title
the time needed to insert the DLT during the period of intubation
Time Frame
12 months
Title
mean blood pressure (MAP) before intubation, and after intubation 1, 3,and 5 min
Time Frame
12 months
Title
the incidence of hypoxemia during the period of intubation
Description
Hypoxemia is defined as the SPO2 is below 90%.
Time Frame
12 months
Title
the heart rate (HR) before intubation, and after intubation 1, 3,and 5 min
Time Frame
12 months
Title
the incidence of sore throat after extubation
Time Frame
12 months
Title
the incidence of hoarseness after extubation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status I-III more than 18 years of age Receiving thoracic surgery with double-lumen endobronchial tube Exclusion Criteria: risk of regurgitation and pulmonary aspiration history of gastroesophageal reflux pregnancy scheduled tracheostomy and postoperative prolonged ventilation in ICU limited neck extension (< 35°) a thyromental distance less than 7 cm a sternomental distance less than 12.5 cm with the head fully extended mouth can not open
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Te Hsu, VS
Organizational Affiliation
Department of anesthesia, Kaoshiung medical university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of anesthesia, Kaohsiung medical university memorial hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25206313
Citation
Hsu HT, Chou SH, Chou CY, Tseng KY, Kuo YW, Chen MC, Cheng KI. A modified technique to improve the outcome of intubation with a left-sided double-lumen endobronchial tube. BMC Anesthesiol. 2014 Aug 18;14:72. doi: 10.1186/1471-2253-14-72. eCollection 2014.
Results Reference
derived

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Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation

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