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

Intubation Complication Clinical Trial

Official title:

The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364622
• Other study ID #: KMUH-IRB-20130194
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: February 17, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation Complication
• Intubation, Difficult

Intervention

Device:
• Tranditional fiberoptic bronchoscopy
The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.
• Modified fiberoptic bronchoscopy
The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy
• Flexible Trachway intubating stylet
The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University chung-Ho Memorial Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea		12 month	Yes
Secondary	The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea		12 month	Yes
Secondary	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 month	Yes
Secondary	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 month	Yes
Secondary	The outcome measure is the incidence of hypoxemia	Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the intubation period.	12 month	Yes
Secondary	The outcome measure is the incidence of sore throat	Sore throat was observed and evaluated after extubation and patient regained consciousness	12 month	Yes
Secondary	The outcome measure is the incidence of hoarseness	Hoarseness was observed and evaluated after extubation and patient regained consciousness	12 month	Yes