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

This study has been completed.
Sponsor:
Collaborator:
SFMU
Information provided by:
Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT00644722
First received: March 24, 2008
Last updated: January 27, 2009
Last verified: January 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 24, 2008
Last Updated: January 27, 2009
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014