Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R)

Not Applicable

• Conditions: Contamination of the Handles; Quality of the Laryngoscopy
• Interventions: Device: 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.

• Registration Number: NCT01632085
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Study First Posted: 2012-06-29
• Last Update Posted: 2012-06-29
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Men or women over 18 years·
• 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

• Contraindication to general anesthesia or one of its components·
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group SU (Single use or 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.	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 ®.
Group R (Reusable handle)	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.	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.

Primary Outcome Measures

Name	Time	Method
The quality of laryngoscopy	1 year	The quality of laryngoscopy. The quality of the visibility of the glottis, is assessed by the Cormack and Lehane grade. A rank of 1 or 2 will be considered a success for the analysis of results.

Secondary Outcome Measures

Name	Time	Method
Evaluation microbiological and evaluation of intubation	1 year	Evaluation microbiological (bacteria, fungi) and identification of bacteria with smears of the handle of laryngoscopes, the Laryngobloc ® and the reusable battery.; Evaluation of intubation: IDS score, satisfaction of the anesthesiologist, intubation time, quality of light offered by the device.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg cedex, Alsace, France