Comparison of Three Laryngoscopes in Difficult Laryngoscopy

NCT02387502 | Completed Results DMC

• 1 other identifier: 123-IEC/01/13
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Intubation with Macintosh laryngoscope

EXPERIMENTAL

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

Device: Intubation- Macintosh laryngoscope

Intubation with MacCoy laryngoscope

ACTIVE COMPARATOR

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

Device: Intubation- MacCoy laryngoscope

Intubation with Airtraq laryngoscope

ACTIVE COMPARATOR

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

Device: Intubation- Airtraq laryngoscope

Interventions

Intubation- Macintosh laryngoscope 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 Macintosh laryngoscope

Intubation- MacCoy laryngoscope 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 MacCoy laryngoscope

Intubation- Airtraq laryngoscope 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.

Intubation with Airtraq laryngoscope

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I and II.
• Posted for elective surgery requiring general anesthesia and tracheal intubation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Medical College, Haldwani: lead

Limitations and Caveats

The intubating anesthetist was not blind to the randomization of the laryngoscope. This could have led to bias. However, the primary outcome i.e. time of intubation was well defined and objective.

Results Point of Contact

• Title: Dr. Geeta Bhandari
• Organization: Govt. Medical College, Haldwani.

bhandari_geetantl@rediff.com

8958267145

Study Officials

• Geeta Bhandari, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 13, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04