Intubation, IntratrachealNCT02769221
Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope
A study testing Rigid video stylet and Video laryngoscope in people with Intubation, Intratracheal, run by Seoul National University Hospital.
Trial summary
This study compare the intubation success rate between video laryngoscope and rigid video stylet in cervical spine surgery patients. Half of patients will receive endotracheal intubation by video laryngscope, other half of patients will receive endotracheal intubation by rigid video laryngoscope. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Rigid video stylet and Video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- 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
- 20~80 years old adult patients, ASA class I-III
- Cervical spine surgery in general anesthesia
Who cannot join
- Patients who did not agree with the study
- History of GERD
- Congenital or acquired lesion like tumor, polyp, trauma, abcess, inflammation, foreign body
- Surgery of trachea or airway
- History of radiation around neck area
- Increased possibility of aspiration
- Coagulation abnormality
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Initial Intubation Success Rate Between Video Laryngoscope and Rigid Video Stylet in Patients Undergoing Cervical Spine Surgery
This study compare the intubation success rate between video laryngoscope and rigid video stylet in cervical spine surgery patients. Half of patients will receive endotracheal intubation by video laryngscope, other half of patients will receive endotracheal intubation by rigid video laryngoscope.
Read the detailed description
Video laryngoscope and lightwand are widely used at endotracheal intubation in cervical spine patients.
Video laryngoscope is useful because of identification of anatomic structure around the oral cavity and vocal cord.
Rigid video stylet resemble lightwand, but it has a video at the end of stylet. So rigid video stylet is useful at confirmation of vocal cord.
- Conditions
- Intubation, Intratracheal
- Being tested
- Rigid video stylet, Video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid video styletDevice
Also called Optiscope
Video laryngoscopeDevice
Also called McGrath
| Study group | Role | What they receive |
|---|---|---|
| Optiscope | Experimental | Endotracheal intubation by rigid video stylet, manufactural named Optiscope. Receives: Device: Rigid video stylet |
| McGrath | Active comparator | Endotracheal intubation by video laryngoscope, manufactural named McGrath. Receives: Device: Video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of success rate between two groups
Measured: immediately
Secondary outcomes (1)
Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat
Measured: Within 24 hours after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 370 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-Pyoung Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769221
- Sponsor's protocol ID
- Rigid video stylet intubation
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wu CN, Ma WH, Wei JQ, Wei HF, Cen QY, Cai QX, Cao Y. Laryngoscope and a new tracheal tube assist lightwand intubation in difficult airways due to unstable cervical spine. PLoS One. 2015 Mar 24;10(3):e0120231. doi: 10.1371/journal.pone.0120231. eCollection 2015.
PubMed 25803435Aziz MF, Abrons RO, Cattano D, Bayman EO, Swanson DE, Hagberg CA, Todd MM, Brambrink AM. First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population. Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ANE.0000000000001084.
PubMed 26579847Silverberg MJ, Li N, Acquah SO, Kory PD. Comparison of video laryngoscopy versus direct laryngoscopy during urgent endotracheal intubation: a randomized controlled trial. Crit Care Med. 2015 Mar;43(3):636-41. doi: 10.1097/CCM.0000000000000751.
PubMed 25479112Dong Y, Li G, Wu W, Su R, Shao Y. Lightwand-guided nasotracheal intubation in oromaxillofacial surgery patients with anticipated difficult airways: a comparison with blind nasal intubation. Int J Oral Maxillofac Surg. 2013 Sep;42(9):1049-53. doi: 10.1016/j.ijom.2013.01.027. Epub 2013 May 25.
PubMed 23712007Kasuya Y, Takahashi E, Nagai M, Ozaki M. [Comparison of Tracheal Intubation Performance between Macintosh Direct Laryngoscope and McGRATH(R) MAC Video Laryngoscope among Anesthesia Trainees]. Masui. 2015 Dec;64(12):1291-6. Japanese.
PubMed 26790337Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath(R) Series 5 Video Laryngoscope by Novice Personnel in a Cervical-immobilized Manikin. J Emerg Med. 2016 Jan;50(1):61-6. doi: 10.1016/j.jemermed.2015.06.079. Epub 2015 Oct 1.
PubMed 26432080Ong J, Lee CL, Lai HY, Lee Y, Chen TY, Shyr MH. A new video intubating device: trachway intubating stylet. Anaesthesia. 2009 Oct;64(10):1145. doi: 10.1111/j.1365-2044.2009.06092.x. No abstract available.
PubMed 19735417Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.
PubMed 23975566Kim JK, Kim JA, Kim CS, Ahn HJ, Yang MK, Choi SJ. Comparison of tracheal intubation with the Airway Scope or Clarus Video System in patients with cervical collars. Anaesthesia. 2011 Aug;66(8):694-8. doi: 10.1111/j.1365-2044.2011.06762.x. Epub 2011 May 13.
PubMed 21564045Turkstra 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 16116013
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Initial Intubation Success Rate Between Video Laryngoscope and Rigid Video Stylet in Patients Undergoing Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT02769221
- Acronym / sponsor ID
- Rigid video stylet intubation
- Conditions
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 May 2016 (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.
This study compare the intubation success rate between video laryngoscope and rigid video stylet in cervical spine surgery patients. Half of patients will receive endotracheal intubation by video laryngscope, other half of patients will receive endotracheal intubation by rigid video laryngoscope.
Detailed description
Video laryngoscope and lightwand are widely used at endotracheal intubation in cervical spine patients.
Video laryngoscope is useful because of identification of anatomic structure around the oral cavity and vocal cord.
Rigid video stylet resemble lightwand, but it has a video at the end of stylet. So rigid video stylet is useful at confirmation of vocal cord.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiscope | Experimental | Device: Rigid video styletEndotracheal intubation by rigid video stylet, manufactural named Optiscope. |
| McGrath | Active comparator | Device: Video laryngoscopeEndotracheal intubation by video laryngoscope, manufactural named McGrath. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20~80 years old adult patients, ASA class I-III
- Cervical spine surgery in general anesthesia
Key exclusion criteria (7 listed)
- Patients who did not agree with the study
- History of GERD
- Congenital or acquired lesion like tumor, polyp, trauma, abcess, inflammation, foreign body
- Surgery of trachea or airway
- History of radiation around neck area
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 |
|---|---|---|
| Rigid video styletAlso: Optiscope | Device | Optiscope |
| Video laryngoscopeAlso: McGrath | Device | McGrath |
Primary outcome
Comparison of success rate between two groups
Time frame: immediately
1 secondary outcome
Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat
Time frame: Within 24 hours after endotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 25803435Wu CN, Ma WH, Wei JQ, Wei HF, Cen QY, Cai QX, Cao Y. Laryngoscope and a new tracheal tube assist lightwand intubation in difficult airways due to unstable cervical spine. PLoS One. 2015 Mar 24;10(3):e0120231. doi: 10.1371/journal.pone.0120231. eCollection 2015.
- Background: PubMed 26579847Aziz MF, Abrons RO, Cattano D, Bayman EO, Swanson DE, Hagberg CA, Todd MM, Brambrink AM. First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population. Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ANE.0000000000001084.
- Background: PubMed 25479112Silverberg MJ, Li N, Acquah SO, Kory PD. Comparison of video laryngoscopy versus direct laryngoscopy during urgent endotracheal intubation: a randomized controlled trial. Crit Care Med. 2015 Mar;43(3):636-41. doi: 10.1097/CCM.0000000000000751.
- Background: PubMed 23712007Dong Y, Li G, Wu W, Su R, Shao Y. Lightwand-guided nasotracheal intubation in oromaxillofacial surgery patients with anticipated difficult airways: a comparison with blind nasal intubation. Int J Oral Maxillofac Surg. 2013 Sep;42(9):1049-53. doi: 10.1016/j.ijom.2013.01.027. Epub 2013 May 25.
- Background: PubMed 26790337Kasuya Y, Takahashi E, Nagai M, Ozaki M. [Comparison of Tracheal Intubation Performance between Macintosh Direct Laryngoscope and McGRATH(R) MAC Video Laryngoscope among Anesthesia Trainees]. Masui. 2015 Dec;64(12):1291-6. Japanese.
- Background: PubMed 26432080Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath(R) Series 5 Video Laryngoscope by Novice Personnel in a Cervical-immobilized Manikin. J Emerg Med. 2016 Jan;50(1):61-6. doi: 10.1016/j.jemermed.2015.06.079. Epub 2015 Oct 1.
- Background: PubMed 19735417Ong J, Lee CL, Lai HY, Lee Y, Chen TY, Shyr MH. A new video intubating device: trachway intubating stylet. Anaesthesia. 2009 Oct;64(10):1145. doi: 10.1111/j.1365-2044.2009.06092.x. No abstract available.
- Background: PubMed 23975566Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.
- Background: PubMed 21564045Kim JK, Kim JA, Kim CS, Ahn HJ, Yang MK, Choi SJ. Comparison of tracheal intubation with the Airway Scope or Clarus Video System in patients with cervical collars. Anaesthesia. 2011 Aug;66(8):694-8. doi: 10.1111/j.1365-2044.2011.06762.x. Epub 2011 May 13.
- 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.
- 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.
Hee-Pyoung Park, MD, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Rigid video stylet and Video laryngoscope in people with Intubation, Intratracheal, 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 2 inclusion and 7 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 13 May 2016. 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-Pyoung 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?
Comparison of success rate between two groups (time frame: immediately). 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 NCT02769221, which also lists 10 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 13 May 2016.