Face-to-face Tracheal Intubation: a Comparison of Airtraq, Glidescope and Fastrach

NCT ID: NCT02286570

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-01-31

Brief Summary

Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.

Detailed Description

The investigators record the demographic and the airway data of the patients (thyromental distance, sternomental distance, mallampati score, mandibula protrusions, interincisor distance..etc). The hemodynamic data of the patients baseline preoperatively, after induction, after insertion of the device, after intubation, and 2 minutes intervals after intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue damage, postoperative sore throat, hoarseness, dysphagia were recorded.

Conditions

Intubation Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

face-to-face intubation of Glidescope

patients were intubated using glidescope by face-to-face approach

Group Type: ACTIVE_COMPARATOR

Glidescope

Intervention Type: DEVICE

videolaryngoscope used for endotracheal intubation

face-to-face intubation with Airtraq

patients were intubated using the Airtraq by face-to-face approach

Group Type: ACTIVE_COMPARATOR

Airtraq

Intervention Type: DEVICE

videolaryngoscope used for endotracheal intubation

face-to-face intubation with fastrach

patients were intubated using the Fastrach by face-to-face approach

Group Type: ACTIVE_COMPARATOR

Fastrach

Intervention Type: DEVICE

intubating laryngeal mask airway used for blind endotracheal intubation

Interventions

Glidescope

videolaryngoscope used for endotracheal intubation

Intervention Type: DEVICE

Airtraq

videolaryngoscope used for endotracheal intubation

Intervention Type: DEVICE

Fastrach

intubating laryngeal mask airway used for blind endotracheal intubation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18-60 years of age
• Elective surgery requiring endotracheal intubation
• Normal airway variables
• BMI< 30

Exclusion Criteria

• < 18 years or > 60 years
• Emergency procedures
• Known difficult airways
• BMI> 30

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Zehra Ipek ARSLAN

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zehra I ARSLAN, Doctor

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Reanimation

Other Identifiers

KOU KAEK 2014/255

Identifier Type: -

Identifier Source: org_study_id