Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room

Intubation Clinical Trial

— Laryngotest  

Official title:

Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876967
• Other study ID #: Laryngotest
• Secondary ID: N°ID RCB 2007-A0
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2009
• Last updated: March 30, 2010
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

Description:

Primary outcome: success of intubation at the first attempt

Secondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient age over 18 who need general anesthesia with orothracheal intubation

Exclusion Criteria:

• patient age under 18 or major assist

• presence of upper airway malformation or abnormality

• cervical or facial trauma

• previous difficult intubation known

• no use of curare

• Body Mass Index over 30kg/m2 if crush induction use

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• metallic single use blade
metallic single use blade
• plastic single use blade
plastic single use blade
• metallic reusable blade
metallic reusable blade

Locations

Country	Name	City	State
France	University Hospital Caen	Caen	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of intubation at the first attempt		immediately	Yes
Secondary	quality of laryngeal exposition (Cormack and Lehanne modify grade)		immediately	Yes
Secondary	duration to success intubation		immediately	Yes
Secondary	Intubation difficult Scale		Immediately	Yes
Secondary	result of intubation procedure		immediately	Yes