Laryngoscope Types and The Cervical Motion

NCT ID: NCT02191904

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

Brief Summary

To ensure minimal cervical motion during the intubation of trauma patients is important for the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.

Intubation is required to secure the airway in patient during an anesthesia management or a mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for intubations. The most widely used laryngoscope type is one with a Macintosh blade. However, various types of laryngoscopes have been developed to be used for in case of difficult intubations, the intubation of the patients with head and neck trauma, or the intubation attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly developed laryngoscopes, integrated with an optical view system.

The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type laryngoscopes, having an angle of 46° at the end of blade and including a camera system that magnifies the image.

The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed type of laryngoscope, including optical imaging system. There is a channel on the device for the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which provides glottis display without any deviation in the normal position of the oral, pharyngeal or the tracheal axes.

In the literature, there are many studies comparing the effects of these newly developed laryngoscopes on cervical motions in different scenarios with cadavers and normal patients. However, in these studies, individual vertebral motion was reported during the placement of the tube, while the angulation of the head and neck and the difficulty of the intubations were not clear.

In this study our first hypothesis was cervical motion during endotracheal intubation in Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one was the endotracheal intubation time is similar to the Macintosh that is used more often.

Conditions

Cervical Motion During Endotracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Truview EVO2®

Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively.

Group Type: ACTIVE_COMPARATOR

Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes

Intervention Type: OTHER

Airtraq®

Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively

Group Type: ACTIVE_COMPARATOR

Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes

Intervention Type: OTHER

Direct laryngoscopy

Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively

Group Type: ACTIVE_COMPARATOR

Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes

Intervention Type: OTHER

Interventions

Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

The patients who will undergo general anesthesia for abdominal surgery, American Society of Anesthesiologists physical status I to III, The patients who were aged between 20 and 75

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Alkin Colak

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Colak A, Copuroglu E, Yilmaz A, Sahin SH, Turan N. A Comparison of the Effects of Different Types of Laryngoscope on the Cervical Motions: Randomized Clinical Trial. Balkan Med J. 2015 Apr;32(2):176-82. doi: 10.5152/balkanmedj.2015.15335. Epub 2015 Apr 1.

Reference Type: DERIVED

PMID: 26167342 (View on PubMed)

Other Identifiers

alkin01

Identifier Type: -

Identifier Source: org_study_id