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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014