Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. (NTI)

Comparison Among Three Different Video Scope Guided Nasotracheal Intubation: a Prospective, Non-randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management; Intubation, Intratracheal
• Intervention / Treatment: Behavioral: video rigid laryngoscope guided nasotracheal intubation; Behavioral: video laryngoscope guided nasotracheal intubation; Behavioral: video fiberoptic scope guided nasotracheal intubation

Detailed Description

A total of 60 eligible patients will be enrolled in this prospective study, they are scheduled to undergo elective oro-maxillofacial surgeries under general anaesthesia with nasotracheal intubation in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. 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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhilin Wu, MD, PhD.; Phone Number: 18963946992; Email: 840916@qq.com
• Study Contact Backup: Name: Yan Sun; Phone Number: 13040939959; Email: 13040939959@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: video rigid laryngoscope group; 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; 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.
Experimental: video laryngoscope group; 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; 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.
Experimental: video fiberoptic scope group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of participants whose oral and nasal mucosa bleeds during intubation	during nasotracheal intubation, whether airway soft tissue is damaged, such as bleeding	within 3 minute
the number of participants whose tracheal ring is pressed and catheter is rotated when intubation	during nasotracheal intubation, record whether the operator presses the tracheal ring and rotates the tracheal tube to assist intubation	within 3 minute
Blood pressure values before and after intubation intubation	record blood pressure values before and after intubation	20 minute
Heart rate values before and after intubation intubation	record heart rate before and after intubation	20 minute
the occurrence of throat complications	inquiry and record intubation related complications, such as sore throat and hoarseness	within 2 hours after surgery

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: nasotracheal intubation
• Other Study ID Numbers: 2022SY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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