- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459481
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
January 13, 2021 updated by: Juhui Liu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown.
In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.
Study Overview
Detailed Description
intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group.
intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.
Study Type
Interventional
Enrollment (Actual)
98
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
-
-
Beijing
-
Beijing, Beijing, China, 100144
- ChineseAMS
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients require nasotracheal intubation
Exclusion Criteria:
- fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 70-degree bending angle group
intubation with a 70-degree bending angle
|
patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
|
Experimental: 90-degree bending angle group
intubation with a 90-degree bending angle
|
patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of nasotracheal intubation
Time Frame: Procedure (From the beginning of intubation to the end of intubation)
|
The percentage of successful nasotracheal intubation
|
Procedure (From the beginning of intubation to the end of intubation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiaoming Deng, MD, Chinese Academy of Medical Sciences and Peking Union Medical College
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 4, 2020
Primary Completion (Actual)
November 3, 2020
Study Completion (Actual)
November 5, 2020
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
January 15, 2021
Last Update Submitted That Met QC Criteria
January 13, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSH-2018-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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