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

Not Applicable

Completed

• Conditions: Anesthesia Intubation Complications
• Interventions: Device: Trachway(R) intubating stylet; Device: Direct laryngoscope (Macintoish laryngoscope)

• Registration Number: NCT01517204
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

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 Timeline

• Status Verified: 2011-05
• Study Start: 2011-05
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-09-16
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trachway(R) intubating stylet	Trachway(R) intubating stylet	Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation.
Direct laryngoscope	Direct laryngoscope (Macintoish laryngoscope)	Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube.

Primary Outcome Measures

Name	Time	Method
Main outcome measure is the successful rate of the first intubation	12 month

Secondary Outcome Measures

Name	Time	Method
The outcome measure is the time needed to insert the DLT	12 months
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.
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.
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.
The outcome measure is the incidence of sore throat.	12 months	Sore throat was observed and evaluated after extubation and patient regained consciousness.
The outcome measure is the incidence of hoarseness.	12 months	Hoarseness was observed and evaluated after extubation and patient regained consciousness.

Trial Locations

Locations (1)

department of anesthesia, Kaohsiung medical university memorial hospital; 🇨🇳 Kaohsiung, Taiwan