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

The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complications
• Intervention / Treatment: Device: Direct laryngoscope (Macintoish laryngoscope); Device: Trachway(R) intubating stylet

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • department of anesthesia, Kaohsiung medical university memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Main outcome measure is the successful rate of the first intubation	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The outcome measure is the time needed to insert the DLT		12 months
The outcome measure is mean blood pressure (MAP) during intubation period	MAP was measured before intubation, and after intubation 1, 3,and 5 min.	12 months
The outcome measure is the heart rate (HR) during intubation period	HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.	12 months
The outcome measure is the incidence of hypoxemia.	Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.	12 months
The outcome measure is the incidence of sore throat.	Sore throat was observed and evaluated after extubation and patient regained consciousness.	12 months
The outcome measure is the incidence of hoarseness.	Hoarseness was observed and evaluated after extubation and patient regained consciousness.	12 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Hung-Te Hsu, VS, Department of anesthesia, Kaoshiung medical university hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 16, 2012
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Efficacy; Trachway(R) intubating stylet; Left sided double lumen endobronchial tube; Intubation complication
• Other Study ID Numbers: KMUH-IRB-990305