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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01632085
First received: June 21, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Contamination of the Handles
Quality of the Laryngoscopy
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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • The quality of laryngoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Evaluation microbiological and evaluation of intubation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 480
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632085

Contacts
Contact: Pierre DIEMUNSCH, Pr 03 88 12 70 76 pierre.diemunsch@chru-strasbourg.fr

Locations
France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg cedex, Alsace, France, 67098
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01632085     History of Changes
Other Study ID Numbers: 5131, 2011-A01548-33
Study First Received: June 21, 2012
Last Updated: June 28, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on April 15, 2014