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

NCT05218590 | Completed

• 1 other identifier: 20220108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation; Video Rigid Stylet

Keywords

Nasotracheal intubation; Nostril; Video rigid laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total success rate

  Procedure (Up to the tube entered the trachea.)

• First-attempt success

  First-attempt of nasal intubation with video rigid stylet.

• 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

  Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.)

• The time for tube insertion

  Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.)

Other Outcomes (1)

• Intubation related adverse events.

  Up to 24 hours after intubation.

Study Arms (2)

Right nostril group

ACTIVE COMPARATOR

Nasal intubation with video rigid stylet was performed through the right nostril.

Device: Video rigid stylet

Left nostril group

PLACEBO COMPARATOR

Nasal intubation with video rigid stylet was performed through the left nostril.

Device: Video rigid stylet

Interventions

Video rigid stylet DEVICE

Nasal intubation was performed using the video rigid stylet.

Left nostril group; Right nostril group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Peking University Hospital of Stomatology: collaborator

Study Sites (1)

Peking University Hospital of Stomatology

Beijing, China

Location

Related Publications (4)

• 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.

  PMID: 34617919 BACKGROUND

• 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.

  PMID: 25113425 BACKGROUND

• 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.

  PMID: 32521054 BACKGROUND

• Wang LK, Zhang X, Wu HY, Cheng T, Xiong GL, Yang XD. Impact of choice of nostril on nasotracheal intubation when using video rigid stylet: a randomized clinical trial. BMC Anesthesiol. 2022 Nov 24;22(1):360. doi: 10.1186/s12871-022-01910-3.

  PMID: 36424554 DERIVED

Study Officials

• Xudong Yang, MD, PhD

  Peking University School and Hospital of Stomatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 1, 2022
• Study Start: February 8, 2022
• Primary Completion: April 15, 2022
• Study Completion: April 16, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)