Comparison of Three Laryngoscopes in Difficult Laryngoscopy

NCT ID: NCT02387502

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

Intubation; Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intubation with Macintosh laryngoscope

40 patients were intubated with Macintosh laryngoscope after simulating difficult laryngoscopy using rigid neck collar.

Group Type: EXPERIMENTAL

Intubation- Macintosh laryngoscope

Intervention Type: DEVICE

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 with MacCoy laryngoscope

40 patients were intubated with MacCoy laryngoscope after simulating difficult laryngoscopy using rigid neck collar.

Group Type: ACTIVE_COMPARATOR

Intubation- MacCoy laryngoscope

Intervention Type: DEVICE

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 with Airtraq laryngoscope

40 patients were intubated with Airtraq laryngoscope after simulating difficult laryngoscopy using rigid neck collar.

Group Type: ACTIVE_COMPARATOR

Intubation- Airtraq laryngoscope

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Government Medical College, Haldwani

OTHER

Sponsor Role: lead

Responsible Party

Bikramjit Das

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geeta Bhandari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, Department of Anesthesiology, G.M.C. Haldwani

Other Identifiers

123-IEC/01/13

Identifier Type: -

Identifier Source: org_study_id