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

Phase 4

Completed

• Conditions: Cardiac Arrest; Coma; Major Trauma; Respiratory Distress; Shock
• Interventions: Device: MacIntosh Green Lite (metal single use laryngoscope blades); Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)

• Registration Number: NCT00644722
• Lead Sponsor: Henri Mondor University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-27
• Study Start: 2008-04
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MacIntosh Green Lite (metal single use laryngoscope blades)	Single use metallic blades
2	MacIntosh Green Spec II (metal reusable laryngoscope blades)	Classic reusable metallic blades

Primary Outcome Measures

Name	Time	Method
Intubation success rate during at the first laryngoscopy	10 min

Secondary Outcome Measures

Name	Time	Method
glottis exposure assessed by Cormack and Lehane classification	1 day
difficult intubation rate assessed by the Intubation Difficult Score (IDS)	1 day
the need for alternative airway techniques and the immediate post intubation complications rate	1 day

Trial Locations

Locations (1)

Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP; 🇫🇷 Creteil, Ile de France, France