- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126344
Nasal Intubation Using King Vision Video Laryngoscopy
September 11, 2020 updated by: Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200011
- Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA physical status 1-2
- general anesthesia with nasotracheal intubation
- anticipated difficult airway
Exclusion Criteria:
- contraindications to nasal intubation
- Patients with a history of anti-hypertensive drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: King Vision video laryngoscope
|
nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
|
EXPERIMENTAL: McGrath MAC video laryngoscope
|
nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
|
ACTIVE_COMPARATOR: Macintosh
|
nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0 min after nasal intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laryngoscopy Time
Time Frame: after expose the glottis
|
time to expose the glottis
|
after expose the glottis
|
Number of Participants With Complications
Time Frame: 24h after surgery
|
sore throat, hoarseness, etc
|
24h after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ACTUAL)
January 1, 2018
Study Completion (ACTUAL)
January 5, 2018
Study Registration Dates
First Submitted
April 19, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (ACTUAL)
April 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 11, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- suny2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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