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

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03514745
• Other study ID #: 20171227
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2018
• Est. completion date: May 2019

Study information

• Verified date: July 2018
• Source: SMG-SNU Boramae Medical Center
• Contact: Jin-Young Hwang, M.D., Ph.D.
• Phone: 82-2-870-2518
• Email: mistyblue15[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• GlideScope
Endobronchial intubation is performed using the GlideScope.
• Lighted stylet
Endobronchial intubation is performed using a lighted stylet.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of intubation attempts	Total intubation attempts are counted.	During endobronchial intubation
Secondary	Difficulty of DLT advancement towards the glottis	It is categorised as very easy, easy, difficult, and very difficult	During endobronchial intubation
Secondary	Resistance to DLT insertion through the glottis	It is categorized as none, mild, and moderate	During endobronchial intubation
Secondary	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
Secondary	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