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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Intubation, Difficult
• Intervention / Treatment: Device: Tranditional fiberoptic bronchoscopy; Device: Modified fiberoptic bronchoscopy; Device: Flexible Trachway intubating stylet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 803
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Tranditional fiberoptic bronchoscopy; The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy.	Device: Tranditional fiberoptic bronchoscopy; The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.
Experimental: Modified fiberoptic bronchoscopy; The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy.	Device: Modified fiberoptic bronchoscopy; The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy
Experimental: Flexible Trachway intubating stylet; We used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus.	Device: Flexible Trachway intubating stylet; The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea		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.	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	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.	12 month
The outcome measure is the incidence of sore throat	Sore throat was observed and evaluated after extubation and patient regained consciousness	12 month
The outcome measure is the incidence of hoarseness	Hoarseness was observed and evaluated after extubation and patient regained consciousness	12 month

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Hung-Te Hsu, MD, Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

General Publications

• Hsu HT, Kuo YW, Ma CW, Su MP, Tseng KY, Li CL, Cheng KI. Trachway(R) flexible stylet facilitates the correct placement of double-lumen endobronchial tube: a prospective, randomized study. BMC Anesthesiol. 2022 Aug 15;22(1):260. doi: 10.1186/s12871-022-01800-8.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: double-lumen endobronchial tube; flexible intubating stylet
• Other Study ID Numbers: KMUH-IRB-20130194