We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644722
First Posted: March 27, 2008
Last Update Posted: January 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SFMU
Information provided by:
Henri Mondor University Hospital
  Purpose
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.

Condition Intervention Phase
Cardiac Arrest Coma Major Trauma Respiratory Distress Shock Device: MacIntosh Green Lite (metal single use laryngoscope blades) Device: MacIntosh Green Spec II (metal reusable laryngoscope blades) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties

Resource links provided by NLM:


Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • Intubation success rate during at the first laryngoscopy [ Time Frame: 10 min ]

Secondary Outcome Measures:
  • glottis exposure assessed by Cormack and Lehane classification [ Time Frame: 1 day ]
  • difficult intubation rate assessed by the Intubation Difficult Score (IDS) [ Time Frame: 1 day ]
  • the need for alternative airway techniques and the immediate post intubation complications rate [ Time Frame: 1 day ]

Estimated Enrollment: 800
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Single use metallic blades
Device: MacIntosh Green Lite (metal single use laryngoscope blades)
metal single use laryngoscope blades
Other Names:
  • Truphatek company -Israel
  • Smiths Medical France company
Active Comparator: 2
Classic reusable metallic blades
Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)
metal reusable laryngoscope blades
Other Names:
  • Truphatek company -Israel
  • Smiths Medical France company

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644722


Locations
France
Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP
Creteil, Ile de France, France, 94010
Sponsors and Collaborators
Henri Mondor University Hospital
SFMU
Investigators
Principal Investigator: XAVIER COMBES, MD Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
  More Information

Responsible Party: XAVIER COMBES MD, Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
ClinicalTrials.gov Identifier: NCT00644722     History of Changes
Other Study ID Numbers: N° 2007-A00350-53
First Submitted: March 24, 2008
First Posted: March 27, 2008
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by Henri Mondor University Hospital:
Intubation
Out-of-hospital
Laryngoscope
Blades
Emergency

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases