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

NCT ID: NCT05218590

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2022-04-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Intubation Video Rigid Stylet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Right nostril group

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

Group Type ACTIVE_COMPARATOR

Video rigid stylet

Intervention Type DEVICE

Nasal intubation was performed using the video rigid stylet.

Left nostril group

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

Group Type PLACEBO_COMPARATOR

Video rigid stylet

Intervention Type DEVICE

Nasal intubation was performed using the video rigid stylet.

Interventions

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Video rigid stylet

Nasal intubation was performed using the video rigid stylet.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Hospital of Stomatology

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Yang Xudong

Project leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xudong Yang, MD, PhD

Role: STUDY_DIRECTOR

Peking University School and Hospital of Stomatology

Locations

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Peking University Hospital of Stomatology

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 34617919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25113425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32521054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36424554 (View on PubMed)

Other Identifiers

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20220108

Identifier Type: -

Identifier Source: org_study_id

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