Airway Management, Intubation, Intratracheal
Conditions
Keywords
nasotracheal intubation
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.
Interventions
BEHAVIORALvideo 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.
BEHAVIORALvideo 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.
BEHAVIORALvideo 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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| average number of intubations | anticipated eight months | average number of nasotracheal intubations for each participant |
| the duration of catheter reaching oropharynx | within 1 minute | time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the oropharynx |
| the duration of catheter reaching glottis | within 1 minute | time requirements for the anterior segment of the endotracheal tube from being put into the nasal cavity to the glottis being exposed |
| successful intubation time | within 3 minute | time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the trachea |
| the first-attempt intubation success rate | anticipated eight months | number of successful first-attempt intubation/total number of intubations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the number of participants whose oral and nasal mucosa bleeds during intubation | within 3 minute | during nasotracheal intubation, whether airway soft tissue is damaged, such as bleeding |
| the number of participants whose tracheal ring is pressed and catheter is rotated when intubation | within 3 minute | during nasotracheal intubation, record whether the operator presses the tracheal ring and rotates the tracheal tube to assist intubation |
| Blood pressure values before and after intubation intubation | 20 minute | record blood pressure values before and after intubation |
| Heart rate values before and after intubation intubation | 20 minute | record heart rate before and after intubation |
| the occurrence of throat complications | within 2 hours after surgery | inquiry and record intubation related complications, such as sore throat and hoarseness |
Contacts
Primary ContactZhilin Wu, MD, PhD.
Backup ContactYan Sun
Outcome results
None listed