Nasal Intubation：a Comparison of Different Endotracheal Tubes

Kaohsiung Medical University

Status: Enrolling

Conditions: Intubation Complication

Treatments: Device: Henan Tuoren Endotracheal Tube; Device: Smiths Portex Tracheal Tubes

Study type: Interventional

Funder types: Other

Identifiers

NCT05112783

KMUHIRB-F(I)-20210124

Details and patient eligibility

About

Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.

Full description

1. Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
2. Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
3. Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV.
4. Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
5. Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
6. Anesthesia intubation inducer：Propofol 1mg/kg
7. Intubation
8. Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
9. Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
10. Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age:20-65 years
• Undergoing oro-maxillofacial surgery
• Opening mouth > 3 cm
• Denied any systemic disease.
• American Society of Anesthesiologists (ASA) class:I-III

Exclusion criteria

• Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance < 6cm)
• Previous head and neck surgery history
• Upper abnormal airway diagnosed
• Easily epistaxis
• Both sides nasal cavities obstruction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Henan Tuoren Endotracheal Tube group

Experimental group

Description:

Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Treatment:

Device: Henan Tuoren Endotracheal Tube

Smiths Portex Tracheal tubes group

Experimental group

Description:

Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Treatment:

Device: Smiths Portex Tracheal Tubes