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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00644722
Acronym
LAMETA
Enrollment
800
Registered
2008-03-27
Start date
2008-04-30
Completion date
2009-01-31
Last updated
2009-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Coma, Major Trauma, Respiratory Distress, Shock

Keywords

Intubation, Out-of-hospital, Laryngoscope, Blades, Emergency

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.

Interventions

DEVICEMacIntosh Green Lite (metal single use laryngoscope blades)

metal single use laryngoscope blades

DEVICEMacIntosh Green Spec II (metal reusable laryngoscope blades)

metal reusable laryngoscope blades

Sponsors

SFMU
CollaboratorUNKNOWN
Henri Mondor University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intubation success rate during at the first laryngoscopy10 min

Secondary

MeasureTime frame
glottis exposure assessed by Cormack and Lehane classification1 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 rate1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026