Clincosm LogoSign in Get a demo

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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01517204
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Direct laryngoscope (Macintoish laryngoscope)
  • Device: Trachway(R) intubating stylet
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
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
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • The Clarus Video System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Main outcome measure is the successful rate of the first intubation [12 month]

    Secondary Outcome Measures

    1. The outcome measure is the time needed to insert the DLT [12 months]

    2. The outcome measure is mean blood pressure (MAP) during intubation period [12 months]

      MAP was measured before intubation, and after intubation 1, 3,and 5 min.

    3. The outcome measure is the heart rate (HR) during intubation period [12 months]

      HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.

    4. The outcome measure is the incidence of hypoxemia. [12 months]

      Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.

    5. The outcome measure is the incidence of sore throat. [12 months]

      Sore throat was observed and evaluated after extubation and patient regained consciousness.

    6. The outcome measure is the incidence of hoarseness. [12 months]

      Hoarseness was observed and evaluated after extubation and patient regained consciousness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT01517204
    Other Study ID Numbers:
    • KMUH-IRB-990305
    First Posted:
    Jan 25, 2012
    Last Update Posted:
    Sep 18, 2012
    Last Verified:
    May 1, 2011
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    Trachway(R) intubating stylet
    Left sided double lumen endobronchial tube
    Efficacy
    Intubation complication

    Study Results

    No Results Posted as of Sep 18, 2012