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Completed

NCT Number: NCT00644722

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

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Coma Consciousness Disorders Disease Attributes Dyspnea Emergencies Heart Arrest Heart Diseases Major Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Respiratory Tract Diseases Shock Signs and Symptoms Signs and Symptoms, Respiratory Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP

Créteil, Île-de-France Region, 94010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MacIntosh Green Lite (metal single use laryngoscope blades)

Device

metal single use laryngoscope blades

Other names: Truphatek company -Israel, Smiths Medical France company

MacIntosh Green Spec II (metal reusable laryngoscope blades)

Device

metal reusable laryngoscope blades

Other names: Truphatek company -Israel, Smiths Medical France company

Primary outcomes

  1. Intubation success rate during at the first laryngoscopy

    Time frame: 10 min

Secondary outcomes

  1. glottis exposure assessed by Cormack and Lehane classification

    Time frame: 1 day

  2. difficult intubation rate assessed by the Intubation Difficult Score (IDS)

    Time frame: 1 day

  3. the need for alternative airway techniques and the immediate post intubation complications rate

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Henri Mondor University Hospital

Other

Collaborators

  • SFMU

Registry information

Official study title

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

Acronym: LAMETA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 27, 2008
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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