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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218590
• Other study ID #: 20220108
• Status: Completed
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: April 16, 2022

Study information

• Verified date: April 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 16, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation
• Muscle Rigidity

Intervention

Device:
• Video rigid stylet
Nasal intubation was performed using the video rigid stylet.

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Peking University Hospital of Stomatology

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intubation related adverse events.	Safety outcome	Up to 24 hours after intubation.
Primary	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	Total success rate	Total success rate of nasal intubation with video rigid stylet.	Procedure (Up to the tube entered the trachea.)
Secondary	First-attempt success	First-attempt success of nasal intubation with video rigid stylet.	First-attempt of nasal intubation with video rigid stylet.
Secondary	Times of intubation-attempts	Times of intubation-attempts.	Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
Secondary	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.)
Secondary	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.)
Secondary	Incidence and severity of epistaxis	Incidence and severity of epistaxis	Procedure (Up to completion of intubation)