Nasal IntubationNCT03126344
Nasal Intubation Using King Vision Video Laryngoscopy
A study testing King Vision video laryngoscope, McGrath MAC video laryngoscope and Macintosh 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 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group [n=30]、 McGrath MAC group [n=30] and Macintosh… 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, McGrath MAC video laryngoscope and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 5 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- general anesthesia with nasotracheal intubation
- anticipated difficult airway
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
Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Comparison King Vision Video Laryngoscopy 、McGrath MAC Video Laryngoscopy With Macintosh Laryngoscopy for Nasal Intubation
This study was designed to determine the comparison between the King Vision video laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group [n=30]、 McGrath MAC group [n=30] and Macintosh group[n=30]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.
- Conditions
- Nasal Intubation
- Being tested
- King Vision video laryngoscope, McGrath MAC video laryngoscope, Macintosh laryngoscope
- Keywords
- King Vision
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 using McGrath MAC video laryngoscope Device after general anesthesia induction
Macintosh laryngoscopeDevice
nasal intubation using Macintosh 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 | Experimental | Not described Receives: Device: McGrath MAC video laryngoscope |
| Macintosh | Active comparator | Not described Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor
Measured: 0 min after nasal intubation
Secondary outcomes (2)
Laryngoscopy Time
time to expose the glottis
Measured: after expose the glottis
Number of Participants With Complications
sore throat, hoarseness, etc
Measured: 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Jun 2017
- Primary completion1 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal IntubationStudies of the same condition, open and under way.
- 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126344
- Sponsor's protocol ID
- suny2
- Status last verified
- Sep 2020
- First submitted
- 19 Apr 2017
- Last updated
- 14 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Zhu H, Liu J, Suo L, Zhou C, Sun Y, Jiang H. A randomized controlled comparison of non-channeled king vision, McGrath MAC video laryngoscope and Macintosh direct laryngoscope for nasotracheal intubation in patients with predicted difficult intubations. BMC Anesthesiol. 2019 Aug 31;19(1):166. doi: 10.1186/s12871-019-0838-z.
PubMed 31470814
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison King Vision Video Laryngoscopy 、McGrath MAC Video Laryngoscopy With Macintosh Laryngoscopy for Nasal Intubation
- ClinicalTrials.gov ID
- NCT03126344
- Acronym / sponsor ID
- suny2
- Conditions
- Nasal Intubation
- Keywords
- King Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 14 Sep 2020
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 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group [n=30]、 McGrath MAC group [n=30] and Macintosh group[n=30]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| King Vision video laryngoscope | Experimental | Device: King Vision video laryngoscope |
| McGrath MAC video laryngoscope | Experimental | Device: McGrath MAC video laryngoscope |
| Macintosh | Active comparator | Device: Macintosh 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
- general anesthesia with nasotracheal intubation
- anticipated difficult airway
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 using McGrath MAC video laryngoscope Device after general anesthesia induction | Device | McGrath MAC video laryngoscope |
| Macintosh laryngoscopenasal intubation using Macintosh laryngoscope Device after general anesthesia induction | Device | Macintosh |
Primary outcome
Time to Intubation
Time frame: 0 min after nasal intubation
the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor
2 secondary outcomes
Laryngoscopy Time
Time frame: after expose the glottis
Number of Participants With Complications
Time frame: 24h after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31470814Zhu H, Liu J, Suo L, Zhou C, Sun Y, Jiang H. A randomized controlled comparison of non-channeled king vision, McGrath MAC video laryngoscope and Macintosh direct laryngoscope for nasotracheal intubation in patients with predicted difficult intubations. BMC Anesthesiol. 2019 Aug 31;19(1):166. doi: 10.1186/s12871-019-0838-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, McGrath MAC video laryngoscope and Macintosh 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: finished, as of the sponsor's last update on 14 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT03126344, which also lists 1 linked publication.
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 14 Sep 2020.