Clinical trial NCT05218590: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Video Rigid Stylet
Keywords: Nasotracheal intubation
Nostril
Video rigid laryngoscope
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University Hospital of Stomatology
First posted: 2022-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. American Society of Anesthesiologists physical status I\~II;
3. Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
4. The expected operation time \< 3 hours;
5. Extubation in operation room and do not scheduled to preventive tracheotomy;
6. Patients who were able to breathe clearly and equally through both nostrils.

Exclusion Criteria:

1. Patients had history of difficult intubation or presented with an anticipated difficult airway;
2. Patients requiring nasogastric tube insertion;
3. Presence of contraindications of nasal intubation;
4. Due to surgical requirement, intubation must be completed through one nostril;
5. Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
6. History of severe epistaxis or epistaxis within a month;
7. Previous history of nasal and/or laryngeal surgery;
8. Previous experience with nasal intubation;
9. History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
10. Participate in other clinical studies;
11. Refusal to sign informed consent.

Primary outcomes:
measure: Total time for intubation
timeFrame: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
Secondary outcomes:
measure: Total success rate
timeFrame: Procedure (Up to the tube entered the trachea.)
measure: First-attempt success
timeFrame: First-attempt of nasal intubation with video rigid stylet.
measure: Times of intubation-attempts
timeFrame: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
measure: The time for device insertion
timeFrame: Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.)
measure: The time for tube insertion
timeFrame: Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.)
measure: Incidence and severity of epistaxis
timeFrame: Procedure (Up to completion of intubation)
Other outcomes:
measure: Intubation related adverse events.
timeFrame: Up to 24 hours after intubation.
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
Study officials:
affiliation: Peking University School and Hospital of Stomatology
name: Xudong Yang, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.