Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades - Full Text View

Sponsors and Collaborators:	Henri Mondor University Hospital SFMU
Information provided by:	Henri Mondor University Hospital
ClinicalTrials.gov Identifier:	NCT00644722

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties

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
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Single use metallic blades	Device: MacIntosh Green Lite (metal single use laryngoscope blades) metal single use laryngoscope blades
2: Active Comparator Classic reusable metallic blades	Device: MacIntosh Green Spec II (metal reusable laryngoscope blades) metal reusable laryngoscope blades

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644722

Contacts

Contact: XAVIER COMBES, MD

33-14-517-9500

xavier.combes@hmn.aphp.fr

Locations

France, Ile De France
Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP	Recruiting
CRETEIL, Ile De France, France, 94010
Contact: XAVIER COMBES, MD 33-14-517-9500 xavier.combes@hmn.aphp.fr
Principal Investigator: XAVIER COMBES, MD

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:	Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR ( XAVIER COMBES MD )
Study ID Numbers:	N° 2007-A00350-53
Study First Received:	March 24, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00644722
Health Authority:	France: Ministry of Health

Keywords provided by Henri Mondor University Hospital:

Intubation
Out-of-hospital
Laryngoscope
Blades
Emergency

Study placed in the following topic categories:

Coma
Heart Diseases
Shock

Wounds and Injuries
Emergencies
Heart Arrest

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009