For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?

Study Overview
=================
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.

Official Title
-----------------
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial

Conditions
-----------------
Intubation, Video Rigid Stylet

Intervention / Treatment
-----------------
* Device: Video rigid stylet


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right nostril group<br>Nasal intubation with video rigid stylet was performed through the right nostril. | Device: Video rigid stylet<br>* Nasal intubation was performed using the video rigid stylet.<br>|
| Placebo Comparator: Left nostril group<br>Nasal intubation with video rigid stylet was performed through the left nostril. | Device: Video rigid stylet<br>* Nasal intubation was performed using the video rigid stylet.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Procedure (From when the device tip entered the nostril to when the tube entered the trachea.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total success rate | Total success rate of nasal intubation with video rigid stylet. | Procedure (Up to the tube entered the trachea.) | 
| First-attempt success | First-attempt success of nasal intubation with video rigid stylet. | First-attempt of nasal intubation with video rigid stylet. | 
| Times of intubation-attempts | Times of intubation-attempts. | Procedure (From when the device tip entered the nostril to when the tube entered the trachea.) | 
| The time for device insertion | The duration from when the device tip entered the nostril to when it passed through the vocal cord. | Procedure (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. | Procedure (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 | Procedure (Up to completion of intubation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasotracheal intubation, Nostril, Video rigid laryngoscope