Endotracheal Tube Shapes for Intubation With Videolaryngoscope

NCT03524547 | Completed DMC

• 2 other identifiers: 2018-01-033-0012018-01-016-003
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to intubate

  the time took from the blade passing through the incisor teeth of the patient to the first end tidal CO2 appears on the anesthesia monitor screen.

  20 minutes after induction started.

Secondary Outcomes (2)

• Numbers of intubation attempts

  20 minutes after induction started.

• Level of difficulty in intubation

  20 minutes after induction started.

Study Arms (2)

J-shaped

EXPERIMENTAL

Endotracheal tube will be molded into a J-shape that is similar to that of Macintosh type blade of a McGrath MAC® videolaryngoscope.

Device: J shaped stylet used for endotracheal intubation

60-degrees

ACTIVE COMPARATOR

Endotracheal tube will be bent 60 degrees.

Device: 60-degrees stylet used for endotracheal intubation

Interventions

J shaped stylet used for endotracheal intubation DEVICE

After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.

J-shaped

60-degrees stylet used for endotracheal intubation DEVICE

After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.

60-degrees

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for the surgery under general anesthesia
• Adult patients from 18 years to 65 years
• American society of Anesthesiologist physical status 1,2,3

You may not qualify if:

• Previously diagnosed for the difficult intubation
• Pregnancy
• Obesity (Body mass index over 40 g/m\^2)

Sponsors & Collaborators

• Eunah Cho, MD: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Eunah Cho, M.D.

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Hyunyoung Lim, M.D.

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 15, 2018
• Study Start: May 28, 2018
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

KR (1)