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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01517204
First received: November 15, 2011
Last updated: September 16, 2012
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The outcome measure is the time needed to insert the DLT [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The outcome measure is mean blood pressure (MAP) during intubation period [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Sore throat was observed and evaluated after extubation and patient regained consciousness.

  • The outcome measure is the incidence of hoarseness. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01517204     History of Changes
Other Study ID Numbers: KMUH-IRB-990305
Study First Received: November 15, 2011
Last Updated: September 16, 2012
Health Authority: United States: Food and Drug Administration
Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014