Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514745
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

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.

Condition or disease Intervention/treatment Phase
Intubation;Difficult Device: GlideScope Device: Lighted stylet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Lighted Stylet and GlideScope for Double-lumen Endobronchial Intubation in Patients With a Predicted Difficult Airway
Actual Study Start Date : May 6, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 2019

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.




Primary Outcome Measures :
  1. Intubation time taken for endobronchial intubation [ Time Frame: During endobronchial intubation ]
    Intubation time is defined as the time elapsed from picking up GlideScope or lighted stylet to confirmation of successful intubation by capnometry.


Secondary Outcome Measures :
  1. Number of intubation attempts [ Time Frame: During endobronchial intubation ]
    Total intubation attempts are counted.

  2. Difficulty of DLT advancement towards the glottis [ Time Frame: During endobronchial intubation ]
    It is categorised as very easy, easy, difficult, and very difficult

  3. Resistance to DLT insertion through the glottis [ Time Frame: During endobronchial intubation ]
    It is categorized as none, mild, and moderate

  4. The incidence and severity of postoperative sore throat [ Time Frame: At 1 and 24 hours after surgery ]
    It is quantified by using a 100-point numerical rating scale (NRS, 0 [no pain], 100 [worst pain imaginable]).

  5. The incidence and severity of postoperative hoarseness [ Time Frame: At 1 and 24 hours after surgery ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514745


Contacts
Layout table for location contacts
Contact: Jin-Young Hwang, M.D., Ph.D. 82-2-870-2518 mistyblue15@naver.com

Locations
Layout table for location information
Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Jin-Young Hwang, M.D.    +82-2-870-2518    mistyblue15@naver.com   
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
Investigators
Layout table for investigator information
Study Director: Jin-Young Hwang, M.D., Ph.D. Seoul Metropolitan Government Seoup National University Boramae Medical Center

Layout table for additonal information
Responsible Party: Jin-Young Hwang, MD.PhD., SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03514745     History of Changes
Other Study ID Numbers: 20171227
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No