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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05112783
Other study ID # KMUHIRB-F(I)-20210124
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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