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

Kaohsiung Medical University Chung-Ho Memorial Hospital60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia Intubation Complications

Interventions

Direct laryngoscope (Macintoish laryngoscope)DEVICE

Direct laryngoscope was used to facilitate the intubation of left-sided DLT.

Trachway(R) intubating styletDEVICE

Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

department of anesthesia, Kaohsiung medical university memorial hospital

Kaohsiung City, Kaohsiung, Taiwan

Outcomes

Primary Outcomes

Main outcome measure is the successful rate of the first intubation

Time frame: 12 month

Secondary Outcomes

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

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

Time frame: 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.

Time frame: 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.

Time frame: 12 months

The outcome measure is the incidence of sore throat.

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

Time frame: 12 months

The outcome measure is the incidence of hoarseness.

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

Time frame: 12 months

Data from ClinicalTrials.gov

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