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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04087837
Other study ID # KMUHIRB-F(I)-20190075
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2019
Est. completion date December 31, 2020

Study information

Verified date January 2021
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea


Description:

In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages. In addition, the advancement of the tube from oropharynx into trachea may assist by either using magic forceps or cuff inflation technique. The aim of the study is to investigate either use a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the trachea. Patients were randomized into three groups by using either bougie or nasogastric tube to facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared with the control group with a conventional technique. Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea were recorded. The incidence of using Magill Forceps to accurately place tube tip into trachea, intubation related side effects and complications were recorded at postoperative time stages.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
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:
bougie
The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.
Nasogastric(NG) tube
The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.

Locations

Country Name City State
Taiwan Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

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 of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea 10 minutes
Primary time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval 10 minutes
Secondary post-intubation induced hoarseness and sore throat A visiting questionnaire is used to measure the condition of post-intubation, including sore throat, hoarseness, dysphagia, nasal occlusion, nosebleed and nasal pain. The score for the measurement of sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe; on the other hand, The score for the measurement of nasal occlusion, nosebleed and nasal pain is divided into yes or no. All the evaluation will be assessed in the next coming morning after the postoperation. 2 days
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