Comparison Among Three Different Video Scope Guided Nasotracheal Intubation.

Airway Management Clinical Trial

— NTI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534451
• Other study ID #: 2022SY
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: Wuhan Union Hospital, China
• Contact: Zhilin Wu, MD, PhD.
• Phone: 18963946992
• Email: 840916[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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) ?~?.

4. Body mass index (BMI) 18.5~24.9kg/m2.

5. Mallampati ?~?.

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.

Related Conditions & MeSH terms

• Airway Management
• Intubation, Intratracheal

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	successful intubation time	time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the trachea	within 3 minute
Primary	the first-attempt intubation success rate	number of successful first-attempt intubation/total number of intubations	anticipated eight months
Primary	average number of intubations	average number of nasotracheal intubations for each participant	anticipated eight months
Secondary	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
Secondary	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
Secondary	Blood pressure values before and after intubation intubation	record blood pressure values before and after intubation	20 minute
Secondary	Heart rate values before and after intubation intubation	record heart rate before and after intubation	20 minute
Secondary	the occurrence of throat complications	inquiry and record intubation related complications, such as sore throat and hoarseness	within 2 hours after surgery