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

Face-to-face Tracheal Intubation With Fastrach or Videolaryngoscopes

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.

Study Overview

• Status: Completed
• Conditions: Intubation Difficult
• Intervention / Treatment: Device: Glidescope; Device: Airtraq; Device: Fastrach

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: face-to-face intubation of Glidescope; patients were intubated using glidescope by face-to-face approach	Device: Glidescope; videolaryngoscope used for endotracheal intubation
Active Comparator: face-to-face intubation with Airtraq; patients were intubated using the Airtraq by face-to-face approach	Device: Airtraq; videolaryngoscope used for endotracheal intubation
Active Comparator: face-to-face intubation with fastrach; patients were intubated using the Fastrach by face-to-face approach	Device: Fastrach; intubating laryngeal mask airway used for blind endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation time	2 minutes	elapsing between the handling of the device till intubation 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mucosal damage	1 minute after removal	blood on the device after removal 1 minute
postoperative minor complications sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia	30 minutes after extubation	sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia 30 minutes
need of optimisation maneuvers	during 15 minutes while intubation	chandy, side-to-side, handling force, up-down, reinserting 15 minutes
hemodynamic changes (mean arteriial pressure)	mmHg	entübation and after 15 minutes

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Zehra I ARSLAN, Doctor, Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: KOU KAEK 2014/255