CClinicalTrials.gg
Status unknownNCT01632085MUURUpdated Jun 29, 2012

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

An interventional study of 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. in Contamination of the Handles and Quality of the Laryngoscopy, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-29.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Contamination of the Handles
  • Quality of the Laryngoscopy
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
480 participants (estimated)

Study arms

  • 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.

  • 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.

Interventions

  • DeviceThe 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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg cedex, Alsace 67098, France
    • 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 · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01632085
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jun 29, 2012
Start date
Jun 2012
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Jun 29, 2012

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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