HoarsenessOptiscopeNCT02073786
Rigid Video Stylet Vs Conventional Lightwand Intubation
A study testing Conventional lightwand intubation and Rigid video stylet in people with Hoarseness and Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hoarseness, Intubation, Sorethroat
- What is being tested?
- Conventional lightwand intubation and Rigid video stylet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Mar 2015
- 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
- Patients scheduled for cervical spine surgery under general anesthesia
- aged between 20- 80 yrs
Who cannot join
- Patient who disagrees to participate this study
- Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
- Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University of Hospital
Seoul, 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: : Rigid Video Stylet Can Provide More Successful Intubation Than Conventional Lightwand Intubation in Patients With Cervical Spine Operation : A Prospective Randomized Study
Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.
- Conditions
- Hoarseness, Intubation, Sorethroat
- Being tested
- Conventional lightwand intubation, Rigid video stylet
- Medical subject headings
- Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional lightwand intubationDevice
Conventional lightwand intubation technique will perform during intubation
Rigid video styletDevice
Also called Optiscope® (Pacific Medical, Seoul, Republic of Korea)
Rigid video stylet will inserted through endotracheal tube before induction. After induction with propofol and remifentanil using TIVA infusion pump, rocuronium 0.6mg/kg were used to facilitate intubation. After 2minutes, board-certificated anesthesiologist perform intubation using Optiscope.
| Study group | Role | What they receive |
|---|---|---|
| Lightwand | Active comparator | Conventional lightwand intubation will performe for intubation Receives: Device: Conventional lightwand intubation |
| Optiscope | Experimental | Rigid video stylet, manufactural named Optiscope, will perform for intubation Receives: Device: Rigid video stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary success rate of intubation
compare primary success rate of intubation using Optiscope with lightwand intubation
Measured: within 90 sec from insertion of device
Secondary outcomes (5)
Intubation time
Check the intubation time (sec) Intubation time defines "from insertion of device to oral cavity of patients to confirm successful intubation"
Measured: within 90 seconds from insertion of device
postoperative complications
check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score
Measured: During PACU stay time expected up to 1hr
postoperative complications
check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score
Measured: 24 hr after operation
hemodynamic change
check the changes of mean blood pressure, heart rate, pulse oximetry before and after intubation
Measured: baseline and 1minute after intubation
number of intubation trial and scooping movements
Check the number of intubation tiral and scooping movements during intubation
Measured: during intubation time, an expected average of 1minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HoarsenessStudies 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
- Outcomes assessor
- Enrolment
- 168 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, Study director, ProfessorEugene Kim, MD, Principal investigator, fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073786
- Sponsor's protocol ID
- Optiscope_SNUH
- Acronym
- Optiscope
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Rigid Video Stylet Can Provide More Successful Intubation Than Conventional Lightwand Intubation in Patients With Cervical Spine Operation : A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02073786
- Acronym / sponsor ID
- Optiscope / Optiscope_SNUH
- Conditions
- Hoarseness, Intubation, Sorethroat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 27 Feb 2014 (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.
Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lightwand | Active comparator | Device: Conventional lightwand intubationConventional lightwand intubation will performe for intubation |
| Optiscope | Experimental | Device: Rigid video styletRigid video stylet, manufactural named Optiscope, will perform for intubation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for cervical spine surgery under general anesthesia
- aged between 20- 80 yrs
Key exclusion criteria (3 listed)
- Patient who disagrees to participate this study
- Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
- Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway
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 |
|---|---|---|
| Conventional lightwand intubationConventional lightwand intubation technique will perform during intubation | Device | Lightwand |
| Rigid video styletAlso: Optiscope® (Pacific Medical, Seoul, Republic of Korea)Rigid video stylet will inserted through endotracheal tube before induction. After induction with propofol and remifentanil using TIVA infusion pump, rocuronium 0.6mg/kg were used to facilitate intubation. After 2minutes, board-certificated anesthesiologist perform intubation using Optiscope. | Device | Optiscope |
Primary outcome
Primary success rate of intubation
Time frame: within 90 sec from insertion of device
compare primary success rate of intubation using Optiscope with lightwand intubation
5 secondary outcomes
Intubation time
Time frame: within 90 seconds from insertion of device
postoperative complications
Time frame: During PACU stay time expected up to 1hr
postoperative complications
Time frame: 24 hr after operation
hemodynamic change
Time frame: baseline and 1minute after intubation
number of intubation trial and scooping movements
Time frame: during intubation time, an expected average of 1minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Related trials for Hoarseness
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruiting
EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia
Spasmodic Dysphonia
Not yet recruitingObservational study
Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy
Shoulder Arthroscopy, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Oropharyngeal Leak Pressure, Airway Management
Recruiting
Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
Hoarseness, Post Operative Complicaiton
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 Conventional lightwand intubation and Rigid video stylet in people with Hoarseness and Intubation, 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 2 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 18 Feb 2015. 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?
Primary success rate of intubation (time frame: within 90 sec from insertion of device). 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 18 Feb 2015.