Nasal Intubation：a Comparison of Different Endotracheal Tubes

Not Applicable

Recruiting

• Conditions: Intubation Complication
• Interventions: Device: Smiths Portex Tracheal Tubes; Device: Henan Tuoren Endotracheal Tube

• Registration Number: NCT05112783
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-16
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smiths Portex Tracheal tubes group	Smiths Portex Tracheal Tubes	Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
Henan Tuoren Endotracheal Tube group	Henan Tuoren Endotracheal Tube	Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea

Primary Outcome Measures

Name	Time	Method
success rate	10 minutes	success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea
time	10 minutes	time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval

Secondary Outcome Measures

Name	Time	Method
post-anesthesia care	2 days	post-intubation induced hoarseness and sore throat intubation related hoarseness and sorethroat at post-anesthesia care unit and the next coming morning

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Sanmin District, Taiwan