Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation

The purpose of this study is to comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complications
• Intervention / Treatment: Procedure: the DLT bending to the right; Procedure: the DLT bending to the left

Detailed Description

Intubation with the double-lumen endotracheal tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as GlideScope(R) videolaryngoscope, 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 different bending type of DLT in tracheal intubation.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • department of anesthesia, Kaohsiung medical university memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American Society of Anesthesiologists physical status I-III
2. more than 18 years of age
3. Receiving thoracic surgery with double-lumen endobronchial tube

Exclusion Criteria:

1. risk of regurgitation and pulmonary aspiration
2. history of gastroesophageal reflux
3. pregnancy
4. scheduled tracheostomy and postoperative prolonged ventilation in ICU
5. limited neck extension (< 35°)
6. a thyromental distance less than 7 cm
7. a sternomental distance less than 12.5 cm with the head fully extended
8. 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the DLT bending to the right	Procedure: the DLT bending to the right; bending the bronchial lumen of DLT 60~90 degrees in the same side with the tracheal lumen; Other Names: different bending mode of DLT
Active Comparator: the DLT bending to the left	Procedure: the DLT bending to the left; bending the bronchial lumen of DLT 60~90 degree opposed to the tracheal lumen; Other Names: different bending mode of DLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Main outcome measure is the successful rate of the first intubation compared with the two bending modes of DLT	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time needed to insert the DLT during the period of intubation		12 months
mean blood pressure (MAP) before intubation, and after intubation 1, 3,and 5 min		12 months
the incidence of hypoxemia during the period of intubation	Hypoxemia is defined as the SPO2 is below 90%.	12 months
the heart rate (HR) before intubation, and after intubation 1, 3,and 5 min		12 months
the incidence of sore throat after extubation		12 months
the incidence of hoarseness after extubation		12 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Hung-Te Hsu, VS, Department of anesthesia, Kaoshiung medical university hospital

Publications and helpful links

General Publications

• Hsu HT, Chou SH, Chou CY, Tseng KY, Kuo YW, Chen MC, Cheng KI. A modified technique to improve the outcome of intubation with a left-sided double-lumen endobronchial tube. BMC Anesthesiol. 2014 Aug 18;14:72. doi: 10.1186/1471-2253-14-72. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 16, 2011
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: left-side double lumen bronchial tube; bending type; GlideScope videolaryngoscope
• Additional Relevant MeSH Terms: Wounds and Injuries; Barotrauma; Decompression Sickness
• Other Study ID Numbers: KMUH-IRB-20110172

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No