NCT05534451

Brief Summary

Nasotracheal intubation (NTI) has become the most optimal alternative to oral endotracheal intubation for oro-maxillofacial surgery because it can offer an excellent vision field of the mouth. Additional benefits include milder oropharynx stimulation, less airway secretions, and better tolerance for long term endotracheal intubation maintenance. Traditional NTI is performed under the guidance of indirect laryngoscope, which is often accompanied by longer maneuver time and adverse complications such as trauma and bleeding. The development of various visualization tools such as video laryngoscope, video fiberoptic scope and video rigid laryngoscope has greatly improved NTI. However, there is no consensus on which one is the best adjunctive device for NTI. Therefore, a study on a comparison of the clinical efficacy of the above three video scope guided methods for NTI will be conducted.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

August 30, 2022

Last Update Submit

August 16, 2023

Conditions

Intubation, IntratrachealAirway Management

Keywords

nasotracheal intubation

Outcome Measures

Primary Outcomes (5)

  • the duration of catheter reaching oropharynx

    time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the oropharynx

    within 1 minute

  • the duration of catheter reaching glottis

    time requirements for the anterior segment of the endotracheal tube from being put into the nasal cavity to the glottis being exposed

    within 1 minute

  • successful intubation time

    time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the trachea

    within 3 minute

  • the first-attempt intubation success rate

    number of successful first-attempt intubation/total number of intubations

    anticipated eight months

  • average number of intubations

    average number of nasotracheal intubations for each participant

    anticipated eight months

Secondary Outcomes (5)

  • the number of participants whose oral and nasal mucosa bleeds during intubation

    within 3 minute

  • the number of participants whose tracheal ring is pressed and catheter is rotated when intubation

    within 3 minute

  • Blood pressure values before and after intubation intubation

    20 minute

  • Heart rate values before and after intubation intubation

    20 minute

  • the occurrence of throat complications

    within 2 hours after surgery

Study Arms (3)

video rigid laryngoscope group

EXPERIMENTAL

Similarly during intubation, the patient should be placed in the supine position with the neutral head. The endoscopic body of video rigid laryngoscope covered by a lubricated endotracheal tube enters the airway through the nasal cavity, then proceeds under visual conditions. When the epiglottis is exposed, if necessary, gently lift the patient's lower jaw so that the glottis is fully visible. The tube is pushed to approach and pass the glottis. Withdraw the endoscopic body while adjusting the depth of tube in the trachea. The intubation ends with tube fixation.

Behavioral: video rigid laryngoscope guided nasotracheal intubation

video laryngoscope group

EXPERIMENTAL

First of all, participants will be asked to take supine position with neutral head. The operator will insert a lubricated endotracheal tube through the nasal cavity into the oropharynx, while he/she holds the handle of video laryngoscope in his/her left hand. Laryngoscope blade can be placed into oral cavity along the right corner of the patient's mouth, and the tongue is pushed to the left by moving the handle. Blade should arrive at a suitable depth to fully expose the epiglottis and glottis. After that, the operator can push the catheter with the right hand to approach and pass the glottis, sometimes Magill forceps are necessary. Finally, the tube is inserted into the trachea to the appropriate depth and fixed firmly.

Behavioral: video laryngoscope guided nasotracheal intubation

video fiberoptic scope group

EXPERIMENTAL

It is suggested to apply paraffin oil to the surface of the insertion tube of video fiberoptic scope, where the friction with the inner wall of the endotracheal catheter will be reduced. The insertion tube together with a lubricated endotracheal tube will be placed into the nasopharynx through the nasal cavity of patient who takes supine position with neutral head. Push the insertion tube slowly and continuously along the airway until cuff passes through the glottis. Next carefully, the endotracheal tube can be delivered into the trachea, and the insertion tube can be withdrawn from the trachea. At last, the tracheal catheter can be fixed after the depth is adjusted to an appropriate level.

Behavioral: video fiberoptic scope guided nasotracheal intubation

Interventions

video laryngoscope guided nasotracheal intubationBEHAVIORAL

According to the kinds of video methods uesd to assist in nasotracheal intubation, participants will be divided into video laryngoscope group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

video laryngoscope group
video rigid laryngoscope guided nasotracheal intubationBEHAVIORAL

According to the kinds of video methods uesd to assist in nasotracheal intubation, participants will be divided into video rigid laryngoscope group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

video rigid laryngoscope group
video fiberoptic scope guided nasotracheal intubationBEHAVIORAL

According to the kinds of video methods uesd to assist in nasotracheal intubation, participants will be randomly divided into video fiberoptic scope group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

video fiberoptic scope group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants scheduled for elective oro-maxillofacial surgery under general anesthesia.
  • Age between 18 and 65 years old.
  • The American Society of Anesthesiologists (ASA) Ⅰ～Ⅱ.
  • Body mass index (BMI) 18.5～24.9kg/m2.
  • Mallampati Ⅰ～Ⅱ.
  • Able to give informed consent.

You may not qualify if:

  • Participants with severe intranasal diseases.
  • Participants with severe and uncontrolled clotting diseases.
  • Participants with skull base fractures and cerebrospinal fluid leakage.
  • Participants with unstable cardiovascular and cerebrovascular diseases, or with poor tolerance to vagal stimulation.
  • Participants who are deemed ineligible for participation in the clinical trial by the investigator.
  • Participants who have to receive the alternative therapy to establish ventilation after the several attempts for nasotracheal intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Park DH, Lee CA, Jeong CY, Yang HS. Nasotracheal intubation for airway management during anesthesia. Anesth Pain Med (Seoul). 2021 Jul;16(3):232-247. doi: 10.17085/apm.21040. Epub 2021 Jul 30.

    PMID: 34352965BACKGROUND

  • Zhang J, Lamb A, Hung O, Hung C, Hung D. Blind nasal intubation: teaching a dying art. Can J Anaesth. 2014 Nov;61(11):1055-6. doi: 10.1007/s12630-014-0223-9. Epub 2014 Aug 15. No abstract available.

    PMID: 25125251BACKGROUND

  • Gorback MS. Inflation of the endotracheal tube cuff as an aid to blind nasal endotracheal intubation. Anesth Analg. 1987 Sep;66(9):916-7. No abstract available.

    PMID: 3619105BACKGROUND

  • Abdallah R, Galway U, You J, Kurz A, Sessler DI, Doyle DJ. A randomized comparison between the Pentax AWS video laryngoscope and the Macintosh laryngoscope in morbidly obese patients. Anesth Analg. 2011 Nov;113(5):1082-7. doi: 10.1213/ANE.0b013e31822cf47d. Epub 2011 Sep 14.

    PMID: 21918156BACKGROUND

  • Tachibana N, Niiyama Y, Yamakage M. Less postoperative sore throat after nasotracheal intubation using a fiberoptic bronchoscope than using a Macintosh laryngoscope: A double-blind, randomized, controlled study. J Clin Anesth. 2017 Jun;39:113-117. doi: 10.1016/j.jclinane.2016.10.026. Epub 2017 Apr 6.

    PMID: 28494884BACKGROUND

  • Enterlein G, Byhahn C; American Society of Anesthesiologists Task Force. [Practice guidelines for management of the difficult airway: update by the American Society of Anesthesiologists task force]. Anaesthesist. 2013 Oct;62(10):832-5. doi: 10.1007/s00101-013-2222-6. German.

    PMID: 24104949BACKGROUND

  • Park EY, Kim JY, Lee JS. Tracheal intubation using the Airtraq: a comparison with the lightwand. Anaesthesia. 2010 Jul;65(7):729-32. doi: 10.1111/j.1365-2044.2010.06376.x. Epub 2010 May 17.

    PMID: 20497149BACKGROUND

Central Study Contacts

Zhilin Wu, MD, PhD.

CONTACT

18963946992840916@qq.com

Yan Sun

CONTACT

1304093995913040939959@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: According to the kinds of video methods uesd to assist in nasotracheal intubation, patients will be randomly divided into video laryngoscope group, video fiberoptic scope group and video rigid laryngoscope group, 20 participants in each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 9, 2022

Study Start

September 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share