Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation

Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation in Patients With a Predicted Difficult Airway

We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation time, number of intubation attempts, difficulty in DLT advancement towards the glottis, postoperative sore throat and hoarseness, and hemodynamic responses during intubation in patients with predicted difficult airways.

Study Overview

• Status: Unknown
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: GlideScope; Device: Lighted stylet

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin-Young Hwang, M.D., Ph.D.; Phone Number: 82-2-870-2518; Email: mistyblue15@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Recruiting
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients undergoing thoracic surgery requiring endobronchial intubation for one-lung ventilation

Exclusion Criteria:

• presence of sore throat and hoarseness
• requirements for postoperative mechanical ventilation
• at risk of aspiration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: GlideScope group; After the induction of anesthesia, endobronchial intubation is performed using the GlideScope.	Device: GlideScope; Endobronchial intubation is performed using the GlideScope.
EXPERIMENTAL: Lighted stylet group; After the induction of anesthesia, endobronchial intubation is performed using a lighted stylet.	Device: Lighted stylet; Endobronchial intubation is performed using a lighted stylet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time taken for endobronchial intubation	Intubation time is defined as the time elapsed from picking up GlideScope or lighted stylet to confirmation of successful intubation by capnometry.	During endobronchial intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	Total intubation attempts are counted.	During endobronchial intubation
Difficulty of DLT advancement towards the glottis	It is categorised as very easy, easy, difficult, and very difficult	During endobronchial intubation
Resistance to DLT insertion through the glottis	It is categorized as none, mild, and moderate	During endobronchial intubation
The incidence and severity of postoperative sore throat	It is quantified by using a 100-point numerical rating scale (NRS, 0 [no pain], 100 [worst pain imaginable]).	At 1 and 24 hours after surgery
The incidence and severity of postoperative hoarseness	Hoarseness is defined as a voice quality different from the preoperative voice and graded as follows: none (no hoarseness), mild (recognized by the patient), moderate (obvious to the investigator), and severe (aphonia).	At 1 and 24 hours after surgery

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center
• Investigators: Study Director: Jin-Young Hwang, M.D., Ph.D., Seoul Metropolitan Government Seoup National University Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2018
• Primary Completion (ANTICIPATED): April 30, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (ACTUAL): May 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 1, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20171227

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No