The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube

Kaohsiung Medical University Chung-Ho Memorial Hospital120 enrolled

Overview

The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.

How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Intubation Complication Intubation, Difficult

Interventions

Tranditional fiberoptic bronchoscopyDEVICE

The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.

Modified fiberoptic bronchoscopyDEVICE

The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy

Flexible Trachway intubating styletDEVICE

The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patients with American Society of Anesthesiologists physical status I-III * More than 18 years of age * Requiring DLT for thoracic surgery Exclusion Criteria: * risk of regurgitation and pulmonary aspiration * history of gastroesophageal reflux, pregnancy * scheduled tracheostomy and postoperative prolonged ventilation in ICU * patients with limited neck extension (\< 35°) * a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm * a sternomental distance of less than 12.5 cm with the head fully extended * mouth can not open

Locations (1)

Kaohsiung Medical University chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, Taiwan

Outcomes

Primary Outcomes

Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea

Time frame: 12 month

Secondary Outcomes

The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea

Time frame: 12 month

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 month

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 month

The outcome measure is the incidence of hypoxemia

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

Time frame: 12 month

The outcome measure is the incidence of sore throat

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

Time frame: 12 month

The outcome measure is the incidence of hoarseness

Hoarseness was observed and evaluated after extubation and patient regained consciousness

Time frame: 12 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.