Intubation; DifficultNCT02430415
Laryngoscope-assisted Lightwand Intubation and Cervical Spine Motion
A study testing laryngoscope-assisted lightwand intubation and traditional lightwand intubation in people with Intubation; Difficult, run by Seoul National University Hospital.
Trial summary
The aim of the study is to compare the effect of the laryngoscope-assisted lightwand intubation technique vs. the conventional lightwand intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- laryngoscope-assisted lightwand intubation and traditional lightwand intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists physical status of 1-2 and age of 18-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.
Who cannot join
- Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
- Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
- Body mass index > 30
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Trial on Comparison of Effects of Two Lightwand Intubation Techniques on Cervical Spine Motion: Laryngoscope-assisted vs. Conventional Lightwand Intubation
The aim of the study is to compare the effect of the laryngoscope-assisted lightwand intubation technique vs. the conventional lightwand intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.
Read the detailed description
In clinical practice, the investigators have occasionally experienced some difficulties in the lightwand intubation in patients with cervical spine instability because manual in-line stabilization during intubation hinders free movements of the lightwand such as advancement, withdrawal, and scooping in the oral cavity. For this reason, jaw thrust is often used to secure enough space for free movements of the lightwand in the oral cavity in the traditional lightwand intubation technique. A recent study showed that laryngoscope-assisted lightwand intubation provided more successful intubation on the first attempt and less scooping movement than the traditional lightwand intubation by facilitating free movements of the lightwand in the oral cavity in patients with cervical immobilization during intubation for cervical spine surgery. In the laryngoscope-assisted lightwand intubation technique, the direct laryngoscope may provide sufficient space for free movements of the lightwand in the oral cavity without jaw thrust, which can result in cervical spine movement. However, the effect of the laryngoscope-assisted lightwand intubation technique on cervical spine motion is not investigated yet.
- Conditions
- Intubation; Difficult
- Being tested
- laryngoscope-assisted lightwand intubation, traditional lightwand intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscope-assisted lightwand intubationDevice
laryngoscope-assisted lightwand intubation
traditional lightwand intubationDevice
traditional lightwand intubation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | laryngoscope-assisted lightwand intubation - traditional lightwand intubation Receives: Device: laryngoscope-assisted lightwand intubation; Device: traditional lightwand intubation |
| Group B | Experimental | traditional lightwand intubation - laryngoscope-assisted lightwand intubation Receives: Device: laryngoscope-assisted lightwand intubation; Device: traditional lightwand intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum cervical spine motion
maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments.
Measured: during tracheal intubation
Secondary outcomes (3)
intubation time
Measured: during tracheal intubation
number of intubation trial
Measured: during tracheal intubation
sore throat, pain score
Measured: after extubation ~ postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Pyung Park, MD PhD, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430415
- Sponsor's protocol ID
- LALI
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-915. doi: 10.1213/01.ane.0000166975.38649.27.
PubMed 16116013Davis 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.
PubMed 10702469Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813.
PubMed 28244946
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on Comparison of Effects of Two Lightwand Intubation Techniques on Cervical Spine Motion: Laryngoscope-assisted vs. Conventional Lightwand Intubation
- ClinicalTrials.gov ID
- NCT02430415
- Acronym / sponsor ID
- LALI
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- 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.
The aim of the study is to compare the effect of the laryngoscope-assisted lightwand intubation technique vs. the conventional lightwand intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.
Detailed description
In clinical practice, the investigators have occasionally experienced some difficulties in the lightwand intubation in patients with cervical spine instability because manual in-line stabilization during intubation hinders free movements of the lightwand such as advancement, withdrawal, and scooping in the oral cavity. For this reason, jaw thrust is often used to secure enough space for free movements of the lightwand in the oral cavity in the traditional lightwand intubation technique. A recent study showed that laryngoscope-assisted lightwand intubation provided more successful intubation on the first attempt and less scooping movement than the traditional lightwand intubation by facilitating free movements of the lightwand in the oral cavity in patients with cervical immobilization during intubation for cervical spine surgery. In the laryngoscope-assisted lightwand intubation technique, the direct laryngoscope may provide sufficient space for free movements of the lightwand in the oral cavity without jaw thrust, which can result in cervical spine movement. However, the effect of the laryngoscope-assisted lightwand intubation technique on cervical spine motion is not investigated yet.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: laryngoscope-assisted lightwand intubation, Device: traditional lightwand intubationlaryngoscope-assisted lightwand intubation - traditional lightwand intubation |
| Group B | Experimental | Device: laryngoscope-assisted lightwand intubation, Device: traditional lightwand intubationtraditional lightwand intubation - laryngoscope-assisted lightwand intubation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists physical status of 1-2 and age of 18-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.
Key exclusion criteria (3 listed)
- Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
- Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
- Body mass index > 30
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 |
|---|---|---|
| laryngoscope-assisted lightwand intubationlaryngoscope-assisted lightwand intubation | Device | Group A, Group B |
| traditional lightwand intubationtraditional lightwand intubation | Device | Group A, Group B |
Primary outcome
maximum cervical spine motion
Time frame: during tracheal intubation
maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments.
3 secondary outcomes
intubation time
Time frame: during tracheal intubation
number of intubation trial
Time frame: during tracheal intubation
sore throat, pain score
Time frame: after extubation ~ postoperative day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Background: PubMed 16116013Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-915. doi: 10.1213/01.ane.0000166975.38649.27.
- Background: PubMed 10702469Davis 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.
- Derived from this study: PubMed 28244946Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813.
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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.
Hee Pyung Park, MD PhD principal investigator
Seoul National University of Hospital
Questions about this trial
What is this clinical trial studying?
A study testing laryngoscope-assisted lightwand intubation and traditional lightwand intubation in people with Intubation; Difficult, run by Seoul National University Hospital.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Pyung Park, MD PhD (82-2-2072-2466, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum cervical spine motion (time frame: during tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430415, which also lists 3 linked publications.
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 Apr 2015.