Nasal IntubationNCT03129399
Comparison of King Vision Video Laryngoscope to McGrath MAC Video Laryngoscope for Nasal Intubation
A study testing King Vision video laryngoscope and McGrath MAC video laryngoscope in people with Nasal Intubation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This study was designed to determine the comparison between the King Vision video laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were divided into 2 groups of 40 patients each.Patients of King Vision group [n=40]and Macintosh group [n=40]were intubated using respective… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Intubation
- What is being tested?
- King Vision video laryngoscope and McGrath MAC video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2017to 20 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status 1-2
- Scheduled for general anesthesia with nasotracheal intubation
- Cormach-Lehane score 3-4
Who cannot join
- contraindications to nasal intubation
- Patients with a history of anti-hypertensive drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Yu Sun, MD,PhD, 0086 13611895542, dr_sunyu@163.com
Haozhen Zhu, MM
About this study
Official title: Nasal Intubation Using the King Vision Video Laryngoscope:a Randomized,Controlled Comparison With McGrath MAC Video Laryngoscope
This study was designed to determine the comparison between the King Vision video laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were divided into 2 groups of 40 patients each.Patients of King Vision group [n=40]and Macintosh group [n=40]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation in difficult airway.
- Conditions
- Nasal Intubation
- Being tested
- King Vision video laryngoscope, McGrath MAC video laryngoscope
- Keywords
- anesthesia, King Vision, videolaryngoscope, nasotracheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Vision video laryngoscopeDevice
nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
McGrath MAC video laryngoscopeDevice
nasal intubation with McGrath MAC video laryngoscope Device after general anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| King Vision video laryngoscope | Experimental | Not described Receives: Device: King Vision video laryngoscope |
| McGrath MAC video laryngoscope | Active comparator | Not described Receives: Device: McGrath MAC video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
from taking of the intubation device to successful intubation
Measured: 0 min after nasal intubation
Secondary outcomes (9)
Hemodynamic changes
heart rate
Measured: 1 min before general anesthesia induction
Hemodynamic changes
heart rate
Measured: 1 min after general anesthesia induction
Hemodynamic changes
heart rate
Measured: 3 min after general anesthesia induction
Hemodynamic changes
heart rate
Measured: 5 min after general anesthesia induction
ease of intubation
VAS scores
Measured: 5 min after nasal intubation
incidence of trauma
sore throat, hoarseness, etc
Measured: 24hour after surgery
incidence of trauma
sore throat, hoarseness, etc
Measured: 1hour after surgery
number of failures
intubation failure
Measured: 5 min after nasal intubation
the degree of Cormach-Lehane
glottic exposure
Measured: 5 min after nasal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start20 May 2017
- Primary completion20 May 2018 (estimated)
- Study completion20 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal IntubationStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129399
- Sponsor's protocol ID
- suny
- Status last verified
- May 2017
- First submitted
- 14 Apr 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intubation Using the King Vision Video Laryngoscope:a Randomized,Controlled Comparison With McGrath MAC Video Laryngoscope
- ClinicalTrials.gov ID
- NCT03129399
- Acronym / sponsor ID
- suny
- Conditions
- Nasal Intubation
- Keywords
- anesthesia, King Vision, videolaryngoscope, nasotracheal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 20 May 2018 (estimated)
- Study completion
- 20 Jun 2018 (estimated)
- First posted
- 26 Apr 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.
This study was designed to determine the comparison between the King Vision video laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were divided into 2 groups of 40 patients each.Patients of King Vision group [n=40]and Macintosh group [n=40]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation in difficult airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| King Vision video laryngoscope | Experimental | Device: King Vision video laryngoscope |
| McGrath MAC video laryngoscope | Active comparator | Device: McGrath MAC video laryngoscope |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status 1-2
- Scheduled for general anesthesia with nasotracheal intubation
- Cormach-Lehane score 3-4
Key exclusion criteria (2 listed)
- contraindications to nasal intubation
- Patients with a history of anti-hypertensive drugs
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 |
|---|---|---|
| King Vision video laryngoscopenasal intubation using King Vision video laryngoscope Device after general anesthesia induction | Device | King Vision video laryngoscope |
| McGrath MAC video laryngoscopenasal intubation with McGrath MAC video laryngoscope Device after general anesthesia induction | Device | McGrath MAC video laryngoscope |
Primary outcome
time to intubation
Time frame: 0 min after nasal intubation
from taking of the intubation device to successful intubation
9 secondary outcomes
Hemodynamic changes
Time frame: 1 min before general anesthesia induction
Hemodynamic changes
Time frame: 1 min after general anesthesia induction
Hemodynamic changes
Time frame: 3 min after general anesthesia induction
Hemodynamic changes
Time frame: 5 min after general anesthesia induction
ease of intubation
Time frame: 5 min after nasal intubation
incidence of trauma
Time frame: 24hour after surgery
incidence of trauma
Time frame: 1hour after surgery
number of failures
Time frame: 5 min after nasal intubation
the degree of Cormach-Lehane
Time frame: 5 min after nasal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King Vision video laryngoscope and McGrath MAC video laryngoscope in people with Nasal Intubation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 3 inclusion and 2 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 23 May 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 China. 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 Yu Sun, MD,PhD (0086-136-1189-5542, dr_sunyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to intubation (time frame: 0 min after nasal intubation). 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 23 May 2017.