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

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02364622
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication; Intubation, Difficult	Device: Tranditional fiberoptic bronchoscopy; Device: Modified fiberoptic bronchoscopy; Device: Flexible Trachway intubating stylet	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea [12 month]

Secondary Outcome Measures

1. The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea [12 month]

2. The outcome measure is mean blood pressure (MAP) during intubation period [12 month]

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

3. The outcome measure is the heart rate (HR) during intubation period [12 month]

   HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min

4. The outcome measure is the incidence of hypoxemia [12 month]

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

5. The outcome measure is the incidence of sore throat [12 month]

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

6. The outcome measure is the incidence of hoarseness [12 month]

   Hoarseness was observed and evaluated after extubation and patient regained consciousness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University chung-Ho Memorial Hospital	Kaohsiung City		Taiwan	803

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02364622
• Other Study ID Numbers: KMUH-IRB-20130194
• First Posted: Feb 18, 2015
• Last Update Posted: Feb 18, 2015
• Last Verified: Oct 1, 2013

• Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital: flexible intubating stylet; double-lumen endobronchial tube

Study Results

No Results Posted as of Feb 18, 2015