- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086668
Fingers Hook Technique to Facilitate Nasotracheal Intubation
June 19, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Tube-Videostylet Assembly for Nasotracheal Intubation Assisted by a Fingers-Hook Technique
to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It is necessary to adequately exposure of glottis during naso-tracheal intubation using video-stylet.
However, inadequate upward epiglottis or over-elevation of arytenoids all inhibit the tube tip smoothly into trachea.
Therefore, the study is to investigate either jaw thrust or fingers-hook technique is advantages of nasotracheal intubation.
Study Type
Interventional
Enrollment (Actual)
80
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
-
-
-
Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University
-
-
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
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Criteria:
Inclusion Criteria:
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring general anesthesia undergoing oxo-maxillofacial surgery
- unlimited mouth open
- unlimited neck motion
Exclusion Criteria:
- mouth open < 3 cm
- Ankylosing arthritis patients.
- BMI≧35 kg/m2
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conventional Jaw thrust Group
an assembly of video-stylet and double curve endotracheal tube with conventional jaw thrust technique to facilitate nasotracheal intubation
|
a video-stylet assisted nasotracheal intubation and facilitate by conventional jaw thrust technique
|
|
Experimental: Fingers hook Group
an assembly of video-stylet and double curve endotracheal tube with fingers-hook technique to facilitate nasotracheal intubation
|
a video-stylet assisted nasotracheal intubation and facilitate by fingers-hook technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
grade of glottic field exposure and nasotracheal difficulty intubation score
Time Frame: half an hour
|
to compare the two different techniques in glottic field exposure and score of nasotracheal difficulty intubations scale
|
half an hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the tube-videostylet assembly range of motion
Time Frame: half an hour
|
range motion of tip of tube-videostylet assembly advanced from nasal cavity to trachea
|
half an hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kuang I Cheng, MD, PhD, Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University,Taiwan
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)
March 27, 2017
Primary Completion (Actual)
November 11, 2018
Study Completion (Actual)
November 5, 2019
Study Registration Dates
First Submitted
February 1, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Actual)
June 21, 2024
Last Update Submitted That Met QC Criteria
June 19, 2024
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KMUHIRB-E(I)-20160019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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