Nasal Intubation：a Comparison of Different Endotracheal Tubes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication
• Intervention / Treatment: Device: Henan Tuoren Endotracheal Tube; Device: Smiths Portex Tracheal Tubes

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pin-Yang Hu, MD; Phone Number: 7035 88673121101; Email: u8901090@gmail.com
• Study Contact Backup: Name: Kuang-I Cheng, PhD; Phone Number: 7035 88673121101; Email: kuaich@kmu.edu.tw

Study Locations

• Taiwan
  • Sanmin District
    • Kaohsiung, Sanmin District, Taiwan, 807
      • Recruiting
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Contact: Pin-Yang Hu, MD; Phone Number: 7035 88673121101; Email: u8901090@gmail.com
      • Contact: Kuang-I Cheng, PhD; Phone Number: 7035 88673121101; Email: kuaich@kmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Henan Tuoren Endotracheal Tube group; Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea	Device: Henan Tuoren Endotracheal Tube; The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.
Experimental: Smiths Portex Tracheal tubes group; Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea	Device: Smiths Portex Tracheal Tubes; The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Pin-Yang Hu, MD, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Endotracheal Tube intubation General Anesthesia (ETGA); nasotracheal tube
• Other Study ID Numbers: KMUHIRB-F(I)-20210124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No