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

Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) : Quality of Laryngoscopy and Bacterial Contamination of the Handle

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 Overview

• Status: Unknown
• Conditions: Contamination of the Handles; Quality of the Laryngoscopy
• Intervention / 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.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alsace
    • Strasbourg cedex, Alsace, France, 67098
      • Recruiting
      • Hôpitaux universitaires de Strasbourg
      • Sub-Investigator: Simone MANGEANT, MD
      • Sub-Investigator: Nadia DHIF, MD
      • Sub-Investigator: Florin DIMACHE, MD
      • Sub-Investigator: Nathalie STOJEBA, MD
      • Sub-Investigator: Alice ILIE, MD
      • Sub-Investigator: Catherine LEHMANN, MD
      • Sub-Investigator: Adriana NASTASIE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 ®.	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 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.
Other: 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 5131; 2011-A01548-33 (Other Identifier: ANSM)