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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03645174
Other study ID # AJIRB-MED-OBS-18-226
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date January 15, 2019

Study information

Verified date March 2019
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In difficult airway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option. Aintree catheter is a device to help change LMA to endotracheal tube, but it needs complex and multiple process. Long endotracheal tube can solve this problem of Aintree catheter. The purpose of this study is proving the efficacy of long endotracheal tube compared to Aintree cathter in fiberoptic-guided intubation through LMA.


Description:

In difficult aiway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option according to Difficult intubation guidelines. First, insert LMA and insert fiberoptic through LMA. Second, insert endotracheal tube using fiberoptic as a guide. This process has several problem. Removal of LMA is impossible, so there is a risk of dislodging of endotracheal tube.

Aintree catheter is developed to this problem. Insert Aintree catheter through LMA using fiberoptic, and remove LMA, finally insert endotracheal tube throug Aintree catheter. But the problem of this method is that the whole process is complex and takes long time. And there is a risk of impeding of endotracheal tube at glottis level because the difference of diameters between endotracheal tube and aintree catheter.

Long endotracheal tube could solve the problems mentioned above. Through LMA, insert endotracheal tube using fiberoptic as a guide. Tube is long enough to remove LMA without a risk of dislodging. And after removal of LMA, tube can be cut for optimizing length.

So the purpose of this study is comparing the efficacy of Aintree catheter method and Long tube method in manikin.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 15, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Residents of Anesthesiology

- Who has less than 10 times of experience of fiberoptic intubation

Exclusion Criteria:

- Who has more than 10 times of experience of fiberoptic intubation

- Who deny participating in the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Using long tube
Fiberoptic-guided intubation through LMA, using long tube
Aintree catheter
Fiberoptic-guided intubation through LMA, using Aintree catheter

Locations

Country Name City State
Korea, Republic of Ajou university school of medicine Suwon Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intubation time from entry of fiberoptic at LMA to Ambu bagging 3 minutes
Secondary Success rate Failure is esophageal intubation or disloding of endotracheal tube in any process 5 minutes
Secondary Difficulty score Subjective score using numeric rating scale (1; extremely easy - 10; extremely difficult) 5 minutes
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