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

NCT01023568 | Terminated Results

• 1 other identifier: 09-902
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation

Keywords

intubation; pediatric; videolaryngoscope devices

Outcome Measures

Primary Outcomes (1)

• Time to Successfully Intubate Patient.

  from start of intubation to successfully intubated up to 5 minutes

Secondary Outcomes (4)

• Mean Hemodynamic Response: Mean Arterial Blood Pressure

  measured at 1 minute interval at induction time and from intubation for 10 minutes

• Cormack-Lehane Grade

  immediately after intubation

• Mean Hemodynamic Response: Heart Rate

  measured at 1 minute interval at induction time and from intubation for 10 minutes.

• Number of Participants Who Experienced Desaturation

  measured at 1 minute interval at induction time and from intubation for 10 minutes.

Study Arms (3)

Macintosh blade

ACTIVE COMPARATOR

Intubation with Macintosh blade laryngoscope

Device: Macintosh blade

Glidescope

ACTIVE COMPARATOR

Intubation with Glidescope laryngoscope

Device: Glidescope

Truview PCD

ACTIVE COMPARATOR

Intubation with the Truview PCD laryngoscope

Device: Truview PCD

Interventions

Macintosh blade DEVICE

Intubation with Macintosh blade laryngoscope

Macintosh blade

Glidescope DEVICE

Intubation with Glidescope laryngoscope.

Glidescope

Truview PCD DEVICE

Intubation with Truview PCD laryngoscope.

Truview PCD

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I-III
• elective general surgical procedures
• from 0-10 years-old

You may not qualify if:

• increase intracranial pressure
• history of severe gastrointestinal reflux
• sore throat
• upper respiratory airway infection
• known or suspected difficult airway or coagulopathy

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Roberta Johnson
• Organization: Cleveland Clinic

johnsor13@ccf.org

216-444-9950

Study Officials

• Julie Niezgoda, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 2, 2017
• Results First Posted: February 2, 2017

Record last verified: 2016-12

Locations

US (1)