Cervical Spine SurgeryNCT01950702
Laryngoscope Asssited Lightwand Intubation
A study testing Laryngoscope assisted lightwand intubation and Lightwand intubation in people with Cervical Spine Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the success rate for intubation of laryngocope assisted lightwand intubation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cervical Spine Surgery
- What is being tested?
- Laryngoscope assisted lightwand intubation and Lightwand intubation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for cervical spine surgery under general anesthesia
Who cannot join
- congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation, or foreign bodies in the upper airway
- history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
- American Society of Anesthesiologists physical status ≥ 3
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University of Hospital
Seoul, Jongno-Gu, 110-799
Hee-Pyung Park, MD PhD, 82-2-2072-2466, hppark@snu.ac.kr
Eugene Kim, MD, 82-2-2072-2469, tomomie@hanmail.net
About this study
Official title: Laryngoscope Assisted Lightwand Can Provide More Successful Intubation Than Lightwand Alone in Patients With Cervical Spine Injury : A Prospective Randomized Study
To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.
Read the detailed description
Light wand intubation is well known for safety intubation in cervical injury patiets. Traditional method of using light wand can damage the supraglottic cavity by scooping the apparatus. The investigators try to evaluate the efficacy of laryngoscope assisted light wand intubation compared to traditional method of using light wand alone.
- Conditions
- Cervical Spine Surgery
- Being tested
- Laryngoscope assisted lightwand intubation, Lightwand intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscope assisted lightwand intubationProcedure or surgery
Also called The Macintosh laryngoscope (female: 3rd blade, male: 4th blade), lightwand (Surch-Lite, Aaron Medical Industries, St. Petersburg, FL)
After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen.
Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position.
The Macintosh laryngoscope (female: 3rd blade, male: 4th blade) was inserted into the oral cavity to provide direct view of the epiglottis and then the tip of the lightwand was placed below the epiglottis.
Lightwand intubationProcedure or surgery
Also called Surch-Lite, Aaron Medical Industries, St. Petersburg, FL
After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen.
Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position.
After 2min from administration of rocuronium, the clinician holds the wand similar to a pencil, stands directly behind the patient's head, inserts the device into the side of the mouth and sweeps the tip to the midline. After confirmation of precise location via clear light source on anterior neck, endotracheal tube was inserted and withdrawn lightwand.
| Study group | Role | What they receive |
|---|---|---|
| Lightwand intubation | Active comparator | After standard total intravenous anesthesia using propofol and remifentanil continuous infusion, traditional lightwand intubation was done by pre-specified anesthesiologist who experienced more than 100 times of lightwand intubation.
Patient's head were fixed at neutral position during all intubation period. Receives: Procedure: Lightwand intubation |
| Laryngoscope assisted lightwand intubation | Experimental | After standard total intravenous anesthesia using propofol and remifentanil continuous infusion, lightwand intubation using specific device(Macintosh laryngosope, female:3/Male:4) was done by pre-specified anesthesiologist who experienced more than 100 times of laryngoscope assisted lightwand intubation. Receives: Procedure: Laryngoscope assisted lightwand intubation |
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 via end tidal CO2 measurement
Measured: up to 60 seconds
Secondary outcomes (2)
lightwand search (=intubation) time
Check the time(sec) from insertion of the lightwand or laryngoscopy into the oral cavity to push the endotracheal tube into the trachea.
Measured: from the insertion of the lightwand or laryngoscope into the oral cavity to the point of transillumination over the cricothyroid membrane within 60 sec.
The times of scooping of lightwand
Within 1min after insertion of lightwand into oral cavity, check the scooping time of lightwand during intubation.
Measured: within 1min after insertion of lightwand
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine SurgeryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee-Pyung Park, MD PhD, Study director, ProfessorEugene Kim, MD, Principal investigator, fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950702
- Sponsor's protocol ID
- php3
- Status last verified
- Oct 2014
- First submitted
- 11 Sep 2013
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngoscope Assisted Lightwand Can Provide More Successful Intubation Than Lightwand Alone in Patients With Cervical Spine Injury : A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01950702
- Acronym / sponsor ID
- php3
- Conditions
- Cervical Spine Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Sep 2013 (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.
To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.
Detailed description
Light wand intubation is well known for safety intubation in cervical injury patiets. Traditional method of using light wand can damage the supraglottic cavity by scooping the apparatus. The investigators try to evaluate the efficacy of laryngoscope assisted light wand intubation compared to traditional method of using light wand alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lightwand intubation | Active comparator | Procedure: Lightwand intubationAfter standard total intravenous anesthesia using propofol and remifentanil continuous infusion, traditional lightwand intubation was done by pre-specified anesthesiologist who experienced more than 100 times of lightwand intubation. Patient's head were fixed at neutral position during all intubation period. |
| Laryngoscope assisted lightwand intubation | Experimental | Procedure: Laryngoscope assisted lightwand intubationAfter standard total intravenous anesthesia using propofol and remifentanil continuous infusion, lightwand intubation using specific device(Macintosh laryngosope, female:3/Male:4) was done by pre-specified anesthesiologist who experienced more than 100 times of laryngoscope assisted lightwand intubation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for cervical spine surgery under general anesthesia
Key exclusion criteria (3 listed)
- congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation, or foreign bodies in the upper airway
- history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
- 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 |
|---|---|---|
| Laryngoscope assisted lightwand intubationAlso: The Macintosh laryngoscope (female: 3rd blade, male: 4th blade), lightwand (Surch-Lite, Aaron Medical Industries, St. Petersburg, FL)After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen. Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position. The Macintosh laryngoscope (female: 3rd blade, male: 4th blade) was inserted into the oral cavity to provide direct view of the epiglottis and then the tip of the lightwand was placed below the epiglottis. | Procedure or surgery | Laryngoscope assisted lightwand intubation |
| Lightwand intubationAlso: Surch-Lite, Aaron Medical Industries, St. Petersburg, FLAfter standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen. Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position. After 2min from administration of rocuronium, the clinician holds the wand similar to a pencil, stands directly behind the patient's head, inserts the device into the side of the mouth and sweeps the tip to the midline. After confirmation of precise location via clear light source on anterior neck, endotracheal tube was inserted and withdrawn lightwand. | Procedure or surgery | Lightwand intubation |
Primary outcome
The success rate of intubation
Time frame: up to 60 seconds
confirm the success intubation via end tidal CO2 measurement
2 secondary outcomes
lightwand search (=intubation) time
Time frame: from the insertion of the lightwand or laryngoscope into the oral cavity to the point of transillumination over the cricothyroid membrane within 60 sec.
The times of scooping of lightwand
Time frame: within 1min after insertion of lightwand
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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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 study director
Professor
Eugene Kim, MD principal investigator
fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscope assisted lightwand intubation and Lightwand intubation in people with Cervical Spine Surgery, run by Seoul National University Hospital 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 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 24 Oct 2014. 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?
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?
The success rate of intubation (time frame: up to 60 seconds). 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 24 Oct 2014.