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RecruitingNCT05112783Updated Dec 15, 2023

Nasal Intubation：a Comparison of Different Endotracheal Tubes

An interventional study of Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal Tubes in Intubation Complication, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Jul 2021, registered Oct 2021).
  • Started Jul 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Intubation Complication

Keywords

  • Endotracheal Tube intubation General Anesthesia (ETGA)
  • nasotracheal tube
03

In context

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceHenan Tuoren Endotracheal Tube

    The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

  • DeviceSmiths Portex Tracheal Tubes

    The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.

06

What researchers measure

Primary outcomes

  1. success rate

    success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea

    Time frame: 10 minutes

  2. time

    time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval

    Time frame: 10 minutes

Secondary outcomes

  1. 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

    Time frame: 2 days

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Sanmin District 807, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05112783
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Nov 9, 2021
Start date
Jul 16, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 15, 2023

Study contacts

Pin-Yang Hu, MD
Contact
u8901090@gmail.com
88673121101 ext. 7035
Kuang-I Cheng, PhD
Contact
kuaich@kmu.edu.tw
88673121101 ext. 7035
Pin-Yang Hu, MD
principal investigator · Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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