We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517204
First Posted: January 25, 2012
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
  Purpose
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.

Condition Intervention
Anesthesia Intubation Complications Device: Direct laryngoscope (Macintoish laryngoscope) Device: Trachway(R) intubating stylet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • Main outcome measure is the successful rate of the first intubation [ Time Frame: 12 month ]

Secondary Outcome Measures:
  • The outcome measure is the time needed to insert the DLT [ Time Frame: 12 months ]
  • The outcome measure is mean blood pressure (MAP) during intubation period [ Time Frame: 12 months ]
    MAP was measured before intubation, and after intubation 1, 3,and 5 min.

  • The outcome measure is the heart rate (HR) during intubation period [ Time Frame: 12 months ]
    HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.

  • The outcome measure is the incidence of hypoxemia. [ Time Frame: 12 months ]
    Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.

  • The outcome measure is the incidence of sore throat. [ Time Frame: 12 months ]
    Sore throat was observed and evaluated after extubation and patient regained consciousness.

  • The outcome measure is the incidence of hoarseness. [ Time Frame: 12 months ]
    Hoarseness was observed and evaluated after extubation and patient regained consciousness.


Enrollment: 60
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Direct laryngoscope
Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube.
Device: Direct laryngoscope (Macintoish laryngoscope)
Direct laryngoscope was used to facilitate the intubation of left-sided DLT.
Other Name: Macintoish laryngoscope
Experimental: Trachway(R) intubating stylet
Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation.
Device: Trachway(R) intubating stylet
Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.
Other Name: The Clarus Video System

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517204


Locations
Taiwan
department of anesthesia, Kaohsiung medical university memorial hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Hung-Te Hsu, VS Department of anesthesia, Kaoshiung medical university hospital
  More Information

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01517204     History of Changes
Other Study ID Numbers: KMUH-IRB-990305
First Submitted: November 15, 2011
First Posted: January 25, 2012
Last Update Posted: September 18, 2012
Last Verified: May 2011

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Trachway(R) intubating stylet
Left sided double lumen endobronchial tube
Efficacy
Intubation complication