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

Intubation Difficult Clinical Trial

Official title:

Face-to-face Tracheal Intubation With Fastrach or Videolaryngoscopes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286570
• Other study ID #: KOU KAEK 2014/255
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2014
• Last updated: March 31, 2015
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Difficult

Intervention

Device:
• Glidescope
videolaryngoscope used for endotracheal intubation
• Airtraq
videolaryngoscope used for endotracheal intubation
• Fastrach
intubating laryngeal mask airway used for blind endotracheal intubation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubation time	2 minutes	elapsing between the handling of the device till intubation 2 minutes
Secondary	mucosal damage	1 minute after removal	blood on the device after removal 1 minute
Secondary	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
Secondary	need of optimisation maneuvers	during 15 minutes while intubation	chandy, side-to-side, handling force, up-down, reinserting 15 minutes
Secondary	hemodynamic changes (mean arteriial pressure)	mmHg	entübation and after 15 minutes