Simple Preparation of Endotracheal Tube

Simple Preparation of Endotracheal Tube for Optimal Angulation During Intubation: A Randomized Controlled Trial

To observe the effect of additional E-tube angulation on intubation time and success rate.

Study Overview

• Status: Completed
• Conditions: Endotracheal Tube
• Intervention / Treatment: Other: Curved-tube

Detailed Description

The hypothesis of this study is that shaping endotracheal tube by end-to-end connection before induction will provide more optimal angulation for endotracheal intubation.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation

Exclusion Criteria:

• Patients with congenital or acquired upper airway lesions
• Patients with high risk of aspiration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curved-tube; Giving additional curve to the endotracheal tube by simple preparation.	Other: Curved-tube; Connecting both ends of the endotracheal tube ("O" shape) for 5-min and releasing it provides additional anterior angle temporarily.
No Intervention: Control; No other manipulation of the endotracheal tube is done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful intubation on first attempt	Whether successful intubation is done on first attempt or on additional attempt	On endotracheal intubation up to 1 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubate (TIT)	The TIT started when the blade first passed the lips, and ended when the the detection of end-tidal CO2 trace	On endotracheal intubation up to 1 min

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Jeong-Hwa Seo, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): May 10, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: JHSeo_angulation

Drug and device information, study documents

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