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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Contamination of the Handles; Quality of the Laryngoscopy

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT01632085

5131

2011-A01548-33 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Group SU (Single use or Laryngobloc ®) ®)

Other group

Description:

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 ®.

Treatment:

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.

Group R (Reusable handle)

Other group

Description:

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.

Treatment:

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.