- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644722
Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades (LAMETA)
Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties
Study Overview
Status
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ile de France
-
Creteil, Ile de France, France, 94010
- Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Single use metallic blades
|
metal single use laryngoscope blades
Other Names:
|
Active Comparator: 2
Classic reusable metallic blades
|
metal reusable laryngoscope blades
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intubation success rate during at the first laryngoscopy
Time Frame: 10 min
|
10 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glottis exposure assessed by Cormack and Lehane classification
Time Frame: 1 day
|
1 day
|
difficult intubation rate assessed by the Intubation Difficult Score (IDS)
Time Frame: 1 day
|
1 day
|
the need for alternative airway techniques and the immediate post intubation complications rate
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: XAVIER COMBES, MD, Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N° 2007-A00350-53
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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