Clinical trial NCT05534451: Comparison Among Three Different Video Scope Guided Nasotracheal Intubation.
Official title: Comparison Among Three Different Video Scope Guided Nasotracheal Intubation: a Prospective, Non-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubation, Intratracheal
Airway Management
Keywords: nasotracheal intubation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the duration of catheter reaching oropharynx
timeFrame: within 1 minute
measure: the duration of catheter reaching glottis
timeFrame: within 1 minute
measure: successful intubation time
timeFrame: within 3 minute
measure: the first-attempt intubation success rate
timeFrame: anticipated eight months
measure: average number of intubations
timeFrame: anticipated eight months
Secondary outcomes:
measure: the number of participants whose oral and nasal mucosa bleeds during intubation
timeFrame: within 3 minute
measure: the number of participants whose tracheal ring is pressed and catheter is rotated when intubation
timeFrame: within 3 minute
measure: Blood pressure values before and after intubation intubation
timeFrame: 20 minute
measure: Heart rate values before and after intubation intubation
timeFrame: 20 minute
measure: the occurrence of throat complications
timeFrame: within 2 hours after surgery
Other outcomes:
Locations:
Study officials:
References:
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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.
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.