Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R)
NCT ID: NCT01632085
Last Updated: 2012-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
480 participants
INTERVENTIONAL
2012-06-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group SU (Single use or Laryngobloc ®) ®)
In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Laryngobloc ®.
The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.
Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®.
Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R.
Group R (Reusable handle)
In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Disposable Metal Blade.
The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.
Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®.
Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R.
Interventions
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The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.
Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®.
Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
* Subject has signed informed consent·
* Suject affiliated to a social protection·
* Subject informed of the results of medical examination
Exclusion Criteria
* General anesthesia without a competitive muscle relaxant·
* Patient with criteria for difficult intubation·
* Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
* Subject in class 4 Mallampati·
* Acts performed in the emergency setting·
* Pregnancy and obstetric procedures·
* Breastfeeding·
* Difficulty in communication with the patient (including obtaining informed consent, evaluation of pain in the recovery Room ·
* Subject in exclusion period (determined by a previous study or a study in progress)
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France
Countries
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Central Contacts
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Other Identifiers
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2011-A01548-33
Identifier Type: OTHER
Identifier Source: secondary_id
5131
Identifier Type: -
Identifier Source: org_study_id