Nasal Intubation：a Comparison of Different Endotracheal Tubes

Intubation Complication Clinical Trial

Official title:

Compare the Effects of Two Different Endotracheal Tubes on The Secretion and Bleeding Volume of Patients During Intubation to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112783
• Other study ID #: KMUHIRB-F(I)-20210124
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Pin-Yang Hu, MD
• Phone: 88673121101
• Email: u8901090[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Device:
• Henan Tuoren Endotracheal Tube
The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.
• Smiths Portex Tracheal Tubes
The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Sanmin District

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea	10 minutes
Primary	time	time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval	10 minutes
Secondary	post-anesthesia care	post-intubation induced hoarseness and sore throat intubation related hoarseness and sorethroat at post-anesthesia care unit and the next coming morning	2 days