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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01632085
Acronym
MUUR
Enrollment
480
Registered
2012-06-29
Start date
2012-06-30
Completion date
2014-06-30
Last updated
2012-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contamination of the Handles, Quality of the Laryngoscopy

Brief 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.

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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
The quality of laryngoscopy1 yearThe 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

MeasureTime frameDescription
Evaluation microbiological and evaluation of intubation1 yearEvaluation 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.

Countries

France

Contacts

Primary ContactPierre DIEMUNSCH, Pr
pierre.diemunsch@chru-strasbourg.fr03 88 12 70 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026