- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693235
Adequate Bending Angle of a Lightwand
Adequate Bending Angle of a Lightwand for Tracheal Intubation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lightwands are very useful device for difficult airway management due to small moth opening, weak teeth, and cervical spine instability. Experienced clinicians use a lightwand while bending it adequately. However, there has been not previous studies to investigate the adequate angle to bend it.
This randomized controlled trial is to compare three angles (70, 80, and 90 degrees) as bending angle of lightwands for safe and efficient tracheal intubation in cases which require the use of lightwands.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 07061
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients who require use of a lightwand for tracheal tubes (i.e. small mouth opening, weak teeth, cervical spine instability)
Exclusion Criteria:
- patients who refuse to participate the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 70 degrees
During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 70 degrees.
|
For tracheal intubation, investigators will bend the tracheal tube combined a lightwand by assigned angles (70, 80, or 90 degrees) for each patient.
Next a practitioner will perform tracheal intubation with the bent tube.
|
|
EXPERIMENTAL: 80 degrees
During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 80 degrees.
|
For tracheal intubation, investigators will bend the tracheal tube combined a lightwand by assigned angles (70, 80, or 90 degrees) for each patient.
Next a practitioner will perform tracheal intubation with the bent tube.
|
|
EXPERIMENTAL: 90 degrees
During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 90 degrees.
|
For tracheal intubation, investigators will bend the tracheal tube combined a lightwand by assigned angles (70, 80, or 90 degrees) for each patient.
Next a practitioner will perform tracheal intubation with the bent tube.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sore throat
Time Frame: After surgery
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After surgery, investigators evaluate VAS score for sore throat of the patients.
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After surgery
|
|
Intubation time
Time Frame: Intraoperative
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from initiation of tracheal intubation with a lightwand after bending it to completion of tracheal intubation
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Intraoperative
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jung-Man Lee, M.D., PhD., SMG-SNU Boramae Medical Center
Publications and helpful links
General Publications
- Agro F, Hung OR, Cataldo R, Carassiti M, Gherardi S. Lightwand intubation using the Trachlight: a brief review of current knowledge. Can J Anaesth. 2001 Jun;48(6):592-9. doi: 10.1007/BF03016838.
- Chen J, Luo W, Wang E, Lu K. Optimal bent length of lightwand for intubation in adults: a randomized, prospective, comparative study. J Int Med Res. 2012;40(4):1519-31. doi: 10.1177/147323001204000432.
- Davis L, Cook-Sather SD, Schreiner MS. Lighted stylet tracheal intubation: a review. Anesth Analg. 2000 Mar;90(3):745-56. doi: 10.1097/00000539-200003000-00044. No abstract available.
- Kim J, Im KS, Lee JM, Ro J, Yoo KY, Kim JB. Relevance of radiological and clinical measurements in predicting difficult intubation using light wand (Surch-lite) in adult patients. J Int Med Res. 2016 Feb;44(1):136-46. doi: 10.1177/0300060515594193. Epub 2015 Dec 7.
- Szigeti CL, Baeuerle JJ, Mongan PD. Arytenoid dislocation with lighted stylet intubation: case report and retrospective review. Anesth Analg. 1994 Jan;78(1):185-6. doi: 10.1213/00000539-199401000-00034. No abstract available.
- Won D, Lee JM, Lee J, Hwang JY, Kim TK, Chang JE, Kim H, Ma S, Min SW. A pilot study comparing three bend angles for lighted stylet intubation. BMC Anesthesiol. 2021 May 17;21(1):148. doi: 10.1186/s12871-021-01369-8.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30-2018-44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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