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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05112783
Enrollment
80
Registered
2021-11-09
Start date
2021-07-16
Completion date
2023-12-31
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Keywords

Endotracheal Tube intubation General Anesthesia (ETGA), nasotracheal tube

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.

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.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
success rate10 minutessuccess rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea
time10 minutestime taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval

Secondary

MeasureTime frameDescription
post-anesthesia care2 dayspost-intubation induced hoarseness and sore throat intubation related hoarseness and sorethroat at post-anesthesia care unit and the next coming morning

Countries

Taiwan

Contacts

Primary ContactPin-Yang Hu, MD
u8901090@gmail.com88673121101
Backup ContactKuang-I Cheng, PhD
kuaich@kmu.edu.tw88673121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026