Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

Intubation Clinical Trial

Official title:

Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01023568
• Other study ID #: 09-902
• Status: Terminated
• Phase: N/A
• First received: December 1, 2009
• Last updated: September 13, 2011
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: September 2011
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL).

The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.

Description:

Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis.

The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-III

• elective general surgical procedures

• from 0-10 years-old

Exclusion Criteria:

• increase intracranial pressure

• history of severe gastrointestinal reflux

• sore throat

• upper respiratory airway infection

• known or suspected difficult airway or coagulopathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• Macintosh blade
Intubation with Macintosh blade laryngoscope
• Glidescope
Intubation with Glidescope laryngoscope.
• Truview PCD
Intubation with Truview PCD laryngoscope.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to successfully intubate patient.		60 seconds	No
Secondary	time to intubation	GS and TV will be tested for mean hemodynamic response and equivalency (to each other) on both time to intubation (equivalency delta of 7 seconds) and proportion with Cormack score of 1 (equivalency delta of 0.05).	60 seconds	No
Secondary	proportion of intubation with Cormack score of 1	GS and TV will be tested for mean hemodynamic response and equivalency (to each other) on both time to intubation (equivalency delta of 7 seconds) and proportion with Cormack score of 1 (equivalency delta of 0.05).	60 seconds	No