Back to resultsFor Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?
Primary Purpose
Intubation, Video Rigid Stylet
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Video rigid stylet
Sponsored by
About this trial
This is an interventional other trial for Intubation focused on measuring Nasotracheal intubation, Nostril, Video rigid laryngoscope
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years;
- American Society of Anesthesiologists physical status I~II;
- Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
- The expected operation time < 3 hours;
- Extubation in operation room and do not scheduled to preventive tracheotomy;
- Patients who were able to breathe clearly and equally through both nostrils.
Exclusion Criteria:
- Patients had history of difficult intubation or presented with an anticipated difficult airway;
- Patients requiring nasogastric tube insertion;
- Presence of contraindications of nasal intubation;
- Due to surgical requirement, intubation must be completed through one nostril;
- Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
- History of severe epistaxis or epistaxis within a month;
- Previous history of nasal and/or laryngeal surgery;
- Previous experience with nasal intubation;
- History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
- Participate in other clinical studies;
- Refusal to sign informed consent.
Sites / Locations
- Peking University Hospital of Stomatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Right nostril group
Left nostril group
Arm Description
Nasal intubation with video rigid stylet was performed through the right nostril.
Nasal intubation with video rigid stylet was performed through the left nostril.
Outcomes
Primary Outcome Measures
Total time for intubation
The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography.
Secondary Outcome Measures
Total success rate
Total success rate of nasal intubation with video rigid stylet.
First-attempt success
First-attempt success of nasal intubation with video rigid stylet.
Times of intubation-attempts
Times of intubation-attempts.
The time for device insertion
The duration from when the device tip entered the nostril to when it passed through the vocal cord.
The time for tube insertion
The duration from when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.
Incidence and severity of epistaxis
Incidence and severity of epistaxis
Full Information
NCT ID
NCT05218590
First Posted
January 30, 2022
Last Updated
April 27, 2022
Sponsor
Peking University
Collaborators
Peking University Hospital of Stomatology
1. Study Identification
Unique Protocol Identification Number
NCT05218590
Brief Title
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?
Official Title
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Peking University Hospital of Stomatology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.
Detailed Description
Head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. It is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. The main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Video Rigid Stylet
Keywords
Nasotracheal intubation, Nostril, Video rigid laryngoscope
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right nostril group
Arm Type
Active Comparator
Arm Description
Nasal intubation with video rigid stylet was performed through the right nostril.
Arm Title
Left nostril group
Arm Type
Placebo Comparator
Arm Description
Nasal intubation with video rigid stylet was performed through the left nostril.
Intervention Type
Device
Intervention Name(s)
Video rigid stylet
Intervention Description
Nasal intubation was performed using the video rigid stylet.
Primary Outcome Measure Information:
Title
Total time for intubation
Description
The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography.
Time Frame
Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
Secondary Outcome Measure Information:
Title
Total success rate
Description
Total success rate of nasal intubation with video rigid stylet.
Time Frame
Procedure (Up to the tube entered the trachea.)
Title
First-attempt success
Description
First-attempt success of nasal intubation with video rigid stylet.
Time Frame
First-attempt of nasal intubation with video rigid stylet.
Title
Times of intubation-attempts
Description
Times of intubation-attempts.
Time Frame
Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
Title
The time for device insertion
Description
The duration from when the device tip entered the nostril to when it passed through the vocal cord.
Time Frame
Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.)
Title
The time for tube insertion
Description
The duration from when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.
Time Frame
Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.)
Title
Incidence and severity of epistaxis
Description
Incidence and severity of epistaxis
Time Frame
Procedure (Up to completion of intubation)
Other Pre-specified Outcome Measures:
Title
Intubation related adverse events.
Description
Safety outcome
Time Frame
Up to 24 hours after intubation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years;
American Society of Anesthesiologists physical status I~II;
Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
The expected operation time < 3 hours;
Extubation in operation room and do not scheduled to preventive tracheotomy;
Patients who were able to breathe clearly and equally through both nostrils.
Exclusion Criteria:
Patients had history of difficult intubation or presented with an anticipated difficult airway;
Patients requiring nasogastric tube insertion;
Presence of contraindications of nasal intubation;
Due to surgical requirement, intubation must be completed through one nostril;
Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
History of severe epistaxis or epistaxis within a month;
Previous history of nasal and/or laryngeal surgery;
Previous experience with nasal intubation;
History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
Participate in other clinical studies;
Refusal to sign informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xudong Yang, MD, PhD
Organizational Affiliation
Peking University School and Hospital of Stomatology
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Hospital of Stomatology
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34617919
Citation
Tan YL, Wu ZH, Zhao BJ, Ni YH, Dong YC. For nasotracheal intubation, which nostril results in less epistaxis: right or left?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Nov 1;38(11):1180-1186. doi: 10.1097/EJA.0000000000001462.
Results Reference
background
PubMed Identifier
25113425
Citation
Boku A, Hanamoto H, Hirose Y, Kudo C, Morimoto Y, Sugimura M, Niwa H. Which nostril should be used for nasotracheal intubation: the right or left? A randomized clinical trial. J Clin Anesth. 2014 Aug;26(5):390-4. doi: 10.1016/j.jclinane.2014.01.016. Epub 2014 Aug 10.
Results Reference
background
PubMed Identifier
32521054
Citation
Cheng T, Wang LK, Wu HY, Yang XD, Zhang X, Jiao L. Shikani Optical Stylet for Awake Nasal Intubation in Patients Undergoing Head and Neck Surgery. Laryngoscope. 2021 Feb;131(2):319-325. doi: 10.1002/lary.28763. Epub 2020 Jun 10.
Results Reference
background
Learn more about this trial
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?
We'll reach out to this number within 24 hrs