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NCT00803751 Clinical Trial

A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

Laryngoscopy Clinical Trial

— Truview  

Official title:
A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00803751
Other study ID # Infant Truview
Secondary ID
Status Completed
Phase N/A
First received December 5, 2008
Last updated February 1, 2010
Start date May 2008
Est. completion date December 2009

Study information
Verified date February 2010
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Months
Eligibility Inclusion Criteria:

1. Age less than one year

2. Requiring general anesthesia and orotracheal intubation

3. Weight less than 10 kg

4. ASA class 1-3

Exclusion Criteria:

1. Documented difficult airway

2. Facial deformities

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Use of Truview EVO2 laryngoscope
will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
• Use of the Macintosh laryngoscope
Intubation using the traditional Macintosh laryngoscope

Locations
Country Name City State
United States Memorial Hermann Hospital - Texas Medical Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of laryngeal view obtained. during laryngoscopy prior to intubation No
Primary Ease of intubation during intubation prior to surgery No
Secondary Time taken for intubation throughout the intubation procedure No
Secondary Presence of bleeding gums or oral injury 2 hours after surgery Yes
See also
  Status Clinical Trial Phase
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Recruiting NCT06037915 - Airway Interventions During Intravenous Anesthesia in Children Undergoing Direct Laryngoscopy for Surgical Procedures Using High Flow Nasal Versus Low Flow Oxygen. A Pilot Study.(Flowkid) Phase 4
Recruiting NCT01937611 - Intramuscular Dexmedetomidine as Premedication Phase 4
Completed NCT03470116 - Comparison Between the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation for Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery. N/A
Completed NCT04701762 - Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy N/A
Completed NCT04259021 - The Voice Analysis as a Preoperative Prediction Method of a Difficult Airway
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Completed NCT03981042 - Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE) N/A
Completed NCT05859542 - Place of the Video-laryngoscope in Learning Intubation by Simulation
Terminated NCT03472118 - High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General Anesthesia N/A
Recruiting NCT06149338 - The Rate of Successful Intubation and the Required Time for Intubation, Using Vie Scope and Macintosh Laryngoscope Will be Compared, in Order to Evaluate the Efficacy of Vie Scope in Comparison With Macintosh in Expected Easy Airways. N/A
Completed NCT00992628 - Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope N/A
Completed NCT03599687 - Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics
Completed NCT03709979 - Effect Of Position On Laryngeal Visualisation With The C-Mac Videolaryngoscope N/A
Not yet recruiting NCT06226532 - Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation Phase 4
Completed NCT01685320 - Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study N/A
Completed NCT03464929 - Learning Curves for Airtraq Versus King Vision Laryngoscopes

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