- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04578119
Optimal Intubating Technique Using Videolaryngoscopy in Patients With Semi-rigid Neck Collar
May 9, 2022 updated by: Do-Hyeong Kim, Gangnam Severance Hospital
Comparison of Sliding Technique and Conventional Technique for Videolaryngoscopy in Patients Undergoing Cervical Spine Surgery With Semi-rigid Neck Collar During Intubation
In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists.
Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For patients who need to limit the movement of the cervical spine, the tracheal intubation becomes difficult because the head must be positioned in the neutral position.
Most of all, with a semi-rigid neck collar that maintains the neutral position of the head and neck, movement is limited and the mouth is not well-opened make the environment of tracheal intubation worse, which result in hypoxia or throat complications related to general anesthesia.
Fortunately, it is possible that the development of video laryngoscope assists tracheal intubation easier for patients who have the limited movement of the cervical spine.
However, the preferred intubation style and instrument selection for each operator are varied; the established method is required.
In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists.
Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- GangnamSeverance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients (over 19 years of age) with ASA class I-III undergoing cervical spine surgery at our institution in the department of spine neurosurgery
Exclusion Criteria:
- When rapid sequence induction is required
- When awake intubation is required
- If a subject is on the medication for asthma
- If as subject cannot read or understand the consent form of study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Conventional Intubating Technique
'Conventional technique' means that endotracheal intubation is performed with the videolayngoscope blade lifting up the epiglottis.
|
|
|
EXPERIMENTAL: Sliding Intubating Technique
'Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly.
|
Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of glottic opening (POGO) score (%)
Time Frame: When we insert the endotracheal tube during anesthetic induction
|
The POGO score represents the percentage of glottic opening seen, defined by the linear span from the anterior commisure to the interarytenoid notch.
|
When we insert the endotracheal tube during anesthetic induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 7, 2020
Primary Completion (ACTUAL)
August 31, 2021
Study Completion (ACTUAL)
September 7, 2021
Study Registration Dates
First Submitted
September 23, 2020
First Submitted That Met QC Criteria
October 2, 2020
First Posted (ACTUAL)
October 8, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 11, 2022
Last Update Submitted That Met QC Criteria
May 9, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 3-2020-0318
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Intubation;Difficult
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Michael MaRecruitingDifficult Intubation | Difficult Airway IntubationIreland
-
Lazarski UniversityCompletedIntubation; Difficult or Failed | Difficult Airway | Intubation;DifficultPoland
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, New Zealand, Singapore, Australia, Austria, India, United Kingdom, Italy, Germany
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
J. Matthias WalzTerminatedSurgery | Difficult Intubation | Anesthesia | Difficult Airway Intubation | Speech DysfunctionUnited States
-
Diskapi Teaching and Research HospitalRecruitingCardiac Surgery | Difficult Intubation | Difficult Airway | Difficult Airway Intubation | Cardiac Surgery in Adult PatientTurkey (Türkiye)
-
Derince Training and Research HospitalCompletedDifficult Intubation | Difficult AirwayTurkey
-
Kutahya Health Sciences UniversityCompletedDifficult Intubation | Difficult Airway | Difficult Mask VentilationTurkey (Türkiye)
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation Complication | Intubation, DifficultTaiwan
Clinical Trials on Sliding Intubating Technique
-
Rodrigo Marcel Valentim da SilvaUnknownTension-Type Headache | Trigger Point
-
University of AlcalaNot yet recruitingLateral Epicondylitis \(Tennis Elbow\)Spain
-
Riphah International UniversityCompletedCervical RadiculopathyPakistan
-
Karolinska InstitutetUniversity Hospital, LinkoepingCompletedPancreatic FistulaSweden
-
Sheffield Teaching Hospitals NHS Foundation TrustCompleted
-
University Hospital PadovaNot yet recruitingIntubation; Difficult or Failed | Neonatal Disease
-
Bnai Zion Medical CenterUnknownAdverse Anesthesia Outcome
-
University Hospital, RouenUnknown