Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades

Cardiac Arrest Clinical Trial

— LAMETA  

Official title:

Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644722
• Other study ID #: N° 2007-A00350-53
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2008
• Last updated: January 27, 2009
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

Description:

All adult patients requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients requiring out-of-hospital intubation

Exclusion Criteria:

• Patient under 18 years old

• Patients with criteria predictive of impossible intubation under direct laryngoscopy

Study Design

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Coma
• Heart Arrest
• Major Trauma
• Respiratory Distress
• Shock

Intervention

Device:
• MacIntosh Green Lite (metal single use laryngoscope blades)
metal single use laryngoscope blades
• MacIntosh Green Spec II (metal reusable laryngoscope blades)
metal reusable laryngoscope blades

Locations

Country	Name	City	State
France	Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP	Creteil	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Henri Mondor University Hospital	SFMU

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation success rate during at the first laryngoscopy		10 min	No
Secondary	glottis exposure assessed by Cormack and Lehane classification		1 day	Yes
Secondary	difficult intubation rate assessed by the Intubation Difficult Score (IDS)		1 day	Yes
Secondary	the need for alternative airway techniques and the immediate post intubation complications rate		1 day	Yes