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Clinical Trials/NCT05112783
NCT05112783
Recruiting
Not Applicable

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country80 target enrollmentJuly 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation Complication
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
80
Locations
1
Primary Endpoint
success rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 16, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

success rate

Time Frame: 10 minutes

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

time

Time Frame: 10 minutes

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

Secondary Outcomes

  • post-anesthesia care(2 days)

Study Sites (1)

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