Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades (LAMETA)

Henri Mondor University Hospital

Status and phase: Completed; Phase 4

Conditions: Shock; Major Trauma; Coma; Cardiac Arrest; Respiratory Distress

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00644722

N° 2007-A00350-53

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

1

Active Comparator group

Description:

Single use metallic blades

Treatment:

Device: MacIntosh Green Lite (metal single use laryngoscope blades)

2

Active Comparator group

Description:

Classic reusable metallic blades

Treatment:

Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)