Long Endotracheal Tube vs. Aintree Intubating Catheter for Fiberoptic-guided Intubation in Manikin

Fiberoptic-guided Endotracheal Intubation Through Laryngeal Mask Airway in Manikin; Long Endotracheal Tube vs. Aintree Intubating Catheter

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: Aintree catheter; Device: Using long tube

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16377
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aintree catheter; Fiberoptic-guided intubation through LMA, using Aintree catheter	Device: Aintree catheter; Fiberoptic-guided intubation through LMA, using Aintree catheter
Experimental: Long tube; Fiberoptic-guided intubation through LMA, using long tube	Device: Using long tube; Fiberoptic-guided intubation through LMA, using long tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	from entry of fiberoptic at LMA to Ambu bagging	3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Failure is esophageal intubation or disloding of endotracheal tube in any process	5 minutes
Difficulty score	Subjective score using numeric rating scale (1; extremely easy - 10; extremely difficult)	5 minutes

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Publications and helpful links

General Publications

• Chae YJ, Lee H, Jun B, Yi IK. Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube. BMC Anesthesiol. 2020 Jun 18;20(1):152. doi: 10.1186/s12871-020-01069-9.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: intubation; Laryngeal mask airway; fiberoptic; Aintree
• Other Study ID Numbers: AJIRB-MED-OBS-18-226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only for personally requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No