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

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

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

Study Overview

• Status: Completed
• Conditions: Intubation; Video Rigid Stylet
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Hospital of stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation related adverse events.	Safety outcome	Up to 24 hours after intubation.

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking University Hospital of Stomatology
• Investigators: Study Director: Xudong Yang, MD, PhD, Peking University School and Hospital of Stomatology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 16, 2022

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Nasotracheal intubation; Nostril; Video rigid laryngoscope
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Rigidity
• Other Study ID Numbers: 20220108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No