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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03086798
Other study ID # KMUHIRB-F(II)-20150058
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2017
Est. completion date September 30, 2019

Study information

Verified date March 2018
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea


Description:

Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill forceps or cuff inflation is advantageous is not determined.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 30, 2019
Est. primary completion date August 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: 1. patients with American Society of Anesthesiologists physical status I-III 2. aged 20-65 years 3. Requiring Nasotracheal Intubation under general anesthesia 4. unlimited mouth open 5. unlimited neck motion Exclusion Criteria: 1. mouth open < 3 cm 2. Ankylosing arthritis patients. 3. BMI?35 kg/m2

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Magill forceps
Magill forceps techniques to facilitate nasotracheal tube advancement into trachea
cuff inflation
cuff inflation techniques to facilitate nasotracheal tube advancement into trachea

Locations

Country Name City State
Taiwan 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 the technique spending time in this time interval and first attempt successful rate to measure the time taken of either using Magill forceps or with cuff inflation techniques in successfully intubated patients 10 minutes
Secondary total intubation time taken measure the whole intubation time taken from tube tip into selected nostril, to nasopharynx, to oropharynx, into trachea, till capnography showing of 3 consecutive CO2 waveforms half an hour
Secondary glottic injury and cuff damages during tube advanced to assess the bleeding point of glottic area and the cuff injury of endotracheal tube half an hour
Secondary postoperative nasal bleeding, sore throat and hoarseness Events of intubating related nasal bleeding were measured on selected nostril and oral cavity at 3 minutes post-intubation. Incidences of sore throat and hoarseness are evaluated before patients out of recovery room and the coming morning 2 days
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