Comparison of Three Laryngoscopes in Difficult Laryngoscopy

Intubation; Difficult Clinical Trial

Official title:

Comparative Evaluation of Macintosh, MacCoy and Airtraq Laryngoscope in Simulated Difficult Laryngoscopy Using Rigid Neck Collar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387502
• Other study ID #: 123-IEC/01/13
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: April 28, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Government Medical College, Haldwani
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.

Description:

Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I and II.

• Posted for elective surgery requiring general anesthesia and tracheal intubation

Exclusion Criteria:

• patients with anticipated difficult airway

• obese (body mass index (BMI)>30) patients

• patients with risk of pulmonary aspiration of gastric contents

• pregnant patients

• patients with airway distortion or trauma.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Device:
• Intubation- Macintosh laryngoscope
Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
• Intubation- MacCoy laryngoscope
In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
• Intubation- Airtraq laryngoscope
In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Haldwani

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of Intubation	Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.	up to 10 minutes	No