Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) (MUUR)
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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 |
- 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.
- 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 |
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| Contact: Pierre DIEMUNSCH, Pr | 03 88 12 70 76 | pierre.diemunsch@chru-strasbourg.fr |
| 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 | |
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 June 17, 2013