Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 2, 2018
CompletedStudy Start
First participant enrolled
May 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 3, 2018
July 1, 2018
12 months
April 20, 2018
July 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of intubation attempts
During endobronchial intubation
Difficulty of DLT advancement towards the glottis
During endobronchial intubation
Resistance to DLT insertion through the glottis
During endobronchial intubation
The incidence and severity of postoperative sore throat
At 1 and 24 hours after surgery
The incidence and severity of postoperative hoarseness
At 1 and 24 hours after surgery
Study Arms (2)
GlideScope group
ACTIVE COMPARATORAfter the induction of anesthesia, endobronchial intubation is performed using the GlideScope.
Lighted stylet group
EXPERIMENTALAfter the induction of anesthesia, endobronchial intubation is performed using a lighted stylet.
Interventions
Endobronchial intubation is performed using a lighted stylet.
Eligibility Criteria
You may qualify if:
- adult patients undergoing thoracic surgery requiring endobronchial intubation for one-lung ventilation
You may not qualify if:
- presence of sore throat and hoarseness
- requirements for postoperative mechanical ventilation
- at risk of aspiration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707, South Korea
Study Officials
- STUDY DIRECTOR
Jin-Young Hwang, M.D., Ph.D.
Seoul Metropolitan Government Seoup National University Boramae Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD.PhD.
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 2, 2018
Study Start
May 6, 2018
Primary Completion
April 30, 2019
Study Completion
May 1, 2019
Last Updated
July 3, 2018
Record last verified: 2018-07