General AnesthesiaNCT03169556
Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients
A study testing Video-laryngoscope guided lightwand and lightwand alone in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Video-laryngoscope guided lightwand and lightwand alone
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2016to 13 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 20- 80 yrs
- Patients scheduled surgery under the general anesthesia
Who cannot join
- Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy
- Patients with body mass index >35kg/m2, hemodynamic instability or loosening teeth
- Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner
- American Society of Anesthesiologists physical status ≥ 3
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.
- Conditions
- General Anesthesia
- Being tested
- Video-laryngoscope guided lightwand, lightwand alone
- Keywords
- Intubation, light wand, video laryngoscopy, cervical spine immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-laryngoscope guided lightwandDevice
Also called Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China)
After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand.
lightwand aloneDevice
Also called LightWand (3960, GE Healthcare, Englewood, USA)
After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination).
| Study group | Role | What they receive |
|---|---|---|
| video-laryngoscope guided lightwand | Experimental | Not described Receives: Device: Video-laryngoscope guided lightwand |
| lightwand | Active comparator | Not described Receives: Device: lightwand alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of intubation
Confirm the success intubation through end-tidal carbon dioxide on a capnography
Measured: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
The duration of intubation
Define as the duration between insertion of lightwand or video-laryngoscope to oral cavity and removal all intubating devices from oral cavity.
Measured: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
Secondary outcomes (6)
number of intubation trial and scooping movements
The number of intubation tiral and scooping movements during intubation
Measured: during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Blood pressure change
The difference between maximum mean blood pressure and minimum blood pressure
Measured: from start of intubation to 5minute after intubation
Injuries of oral cavity
Check any blood in lips, teeth, endotracheal cuff, and oral cavity
Measured: at immediate after intubation and extubation
Postoperative hoarseness
Check "Yes or No" through questioning the patient
Measured: at 1hr after PACU arrival and 24hr after operation
Postoperative sore throat
Check using visual analog scale (0-100 points)
Measured: at 1hr after PACU arrival and 24hr after operation
Heart rate change
The difference between maximum heart rate and minimum minimum heart rate
Measured: from start of intubation to 5minute after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start19 Dec 2016
- Primary completion13 Oct 2017
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169556
- Sponsor's protocol ID
- 1-2016-0069
- Status last verified
- Oct 2017
- First submitted
- 17 May 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients
- ClinicalTrials.gov ID
- NCT03169556
- Acronym / sponsor ID
- 1-2016-0069
- Conditions
- General Anesthesia
- Keywords
- Intubation, light wand, video laryngoscopy, cervical spine immobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video-laryngoscope guided lightwand | Experimental | Device: Video-laryngoscope guided lightwand |
| lightwand | Active comparator | Device: lightwand alone |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 20- 80 yrs
- Patients scheduled surgery under the general anesthesia
Key exclusion criteria (4 listed)
- Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy
- Patients with body mass index >35kg/m2, hemodynamic instability or loosening teeth
- Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner
- American Society of Anesthesiologists physical status ≥ 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-laryngoscope guided lightwandAlso: Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China)After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand. | Device | video-laryngoscope guided lightwand |
| lightwand aloneAlso: LightWand (3960, GE Healthcare, Englewood, USA)After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination). | Device | lightwand |
Primary outcome
The success rate of intubation
Time frame: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
Confirm the success intubation through end-tidal carbon dioxide on a capnography
The duration of intubation
Time frame: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
Define as the duration between insertion of lightwand or video-laryngoscope to oral cavity and removal all intubating devices from oral cavity.
6 secondary outcomes
number of intubation trial and scooping movements
Time frame: during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Blood pressure change
Time frame: from start of intubation to 5minute after intubation
Injuries of oral cavity
Time frame: at immediate after intubation and extubation
Postoperative hoarseness
Time frame: at 1hr after PACU arrival and 24hr after operation
Postoperative sore throat
Time frame: at 1hr after PACU arrival and 24hr after operation
Heart rate change
Time frame: from start of intubation to 5minute after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-laryngoscope guided lightwand and lightwand alone in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of intubation (time frame: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.