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

N/AUnknownNCT01632085

University Hospital, Strasbourg, France480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

480

Conditions

Contamination of the Handles Quality of the Laryngoscopy

Interventions

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.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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, France

RECRUITING

Outcomes

Primary Outcomes

The quality of laryngoscopy

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.

Time frame: 1 year

Secondary Outcomes

Evaluation microbiological and evaluation of intubation

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.

Time frame: 1 year

Central Contacts

Pierre DIEMUNSCH, Pr

CONTACT

03 88 12 70 76 pierre.diemunsch@chru-strasbourg.fr

Data from ClinicalTrials.gov

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